POLYETHYLENE GLYCOL 3350
UNII G2M7P15E5P

Substance Identification & Data

This profile provides standardized clinical and technical data for Polyethylene Glycol 3350, uniquely identified by the FDA Unique Ingredient Identifier (UNII) G2M7P15E5P.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 25322-68-3 and the RxNorm Concept ID (RxCUI) 221147. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
G2M7P15E5P
CAS Registry Number
25322-68-3
RxNorm Concept ID
221147

Detailed Substance Profile

Preferred Name
POLYETHYLENE GLYCOL 3350
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
G2M7P15E5P
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C80131
National Cancer Institute reference terminology for clinical and research data.
Substance Type
polymer
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Polyethylene Glycol 3350. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

PEG-75

Common Names & Synonyms

CARBOWAX PEG 3350
GOLYTELY
HALFLYTELY COMPONENT POLYETHYLENE GLYCOL 3350
MACROGOL 3350
MACROGOL 3350 [WHO-DD]
PEG 3350
PEG-3350
PEG-3350 [VANDF]
PEG-70
PEG-75 [VANDF]
POLYETHYLENE GLYCOL [MI]
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 [II]
POLYETHYLENE GLYCOL 3350 [ORANGE BOOK]
POLYETHYLENE GLYCOL 3350 [USP MONOGRAPH]
POLYETHYLENE GLYCOL 3350 [USP-RS]
POLYETHYLENE GLYCOL 3350 [VANDF]
POLYETHYLENE GLYCOL 3400
POLYETHYLENE GLYCOL 75
POLYETHYLENE GLYCOL 75 [VANDF]
UPIWAX 3350

Brand / Trade Names

CARBOWAX 3350
LIPO POLYGLYCOL 3350
LIPOXOL 3350 MED
LUMULSE PEG 3350
MIRALAX
POLYGLYKOL 3350
PROTACHEM 75

Technical Codes

NER1006
NER-1006
PEG-BASED LAXATIVE NER1006

NDC Products Containing POLYETHYLENE GLYCOL 3350

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (500), only Active Listings are currently displayed. Display is limited to the first 200 products.
→ AbbVie Inc. 7
→ Actavis Pharma, Inc. 7
→ Amneal Pharmaceuticals of New York LLC 2
→ Amphastar Pharmaceuticals, Inc. 4
→ AstraZeneca Pharmaceuticals LP 5
→ Baxter Healthcare Corporation 3
→ Beutlich Pharmaceuticals LLC 2
→ Beutlich Pharmaceuticals, LLC 20
→ Cosette Pharmaceuticals, Inc. 4
→ ENDO USA, Inc. 1
→ Eli Lilly and Company 3
→ Exeltis USA, Inc. 1
→ Galderma Laboratories, L.P. 1
→ Haleon US Holdings LLC 2
→ Henry Schein Inc. 8
→ Hikma Pharmaceuticals USA Inc 2
→ Hikma Pharmaceuticals USA Inc. 2
→ L. Perrigo Company 4
→ Lannett Company Inc. 2
→ MAJOR PHARMACEUTICALS 2
→ Major Pharmaceuticals 7
→ Merck Sharp & Dohme LLC 13
→ Mylan Pharmaceuticals Inc. 2
→ NCS HealthCare of KY, LLC dba Vangard Labs 14
→ PAI Holdings, LLC dba PAI Pharma 1
→ Padagis US LLC 1
→ Pfizer Laboratories Div Pfizer Inc 15
→ Pharmacia & Upjohn Company LLC 8
→ Rugby Laboratories 1
→ Sandoz Inc. 1
→ SpecGx LLC 3
→ Takeda Pharmaceuticals America, Inc. 5
→ Teva Pharmaceuticals USA, Inc. 21
→ Teva Pharmaceuticals, Inc. 13
→ Upsher-Smith Laboratories, LLC 2
→ WALGREEN COMPANY 1
→ WALGREENS 2
→ Walgreen Company 3
→ Walgreens 4
→ Walgreens Company 1

AbbVie Inc.

NDC Product
Human Prescription Drug

Kaletra
NDC 0074-0522

Generic Name
Lopinavir And Ritonavir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Oriahnn
NDC 0074-1017

Generic Name
Elagolix And Estradiol And Norethisterone
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Mavyret
NDC 0074-2600

Generic Name
Glecaprevir And Pibrentasvir
Dosage Form
Pellet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Mavyret
NDC 0074-2625

Generic Name
Glecaprevir And Pibrentasvir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Norvir
NDC 0074-3399

Generic Name
Ritonavir
Dosage Form
Powder
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kaletra
NDC 0074-3956

Generic Name
Lopinavir And Ritonavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Kaletra
NDC 0074-6799

Generic Name
Lopinavir And Ritonavir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Mesalamine
NDC 0591-2245

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alvimopan
NDC 0591-2312

Generic Name
Alvimopan
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0591-2312

Generic Name
Alvimopan
Dosage Form
Capsule
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Drug For Further Processing

NDC 0591-2405

Generic Name
Ambrisentan
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Ambrisentan
NDC 0591-2405

Generic Name
Ambrisentan
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ambrisentan
NDC 0591-2406

Generic Name
Ambrisentan
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0591-2406

Generic Name
Ambrisentan
Dosage Form
Tablet, Film Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Ultramicrosize Griseofulvin
NDC 0115-1724

Generic Name
Ultramicrosize Griseofulvin Tablets
Dosage Form
Tablet, Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ultramicrosize Griseofulvin
NDC 0115-1725

Generic Name
Ultramicrosize Griseofulvin Tablets
Dosage Form
Tablet, Coated
Route
Oral
Marketing
ANDA
Active Listing

Amphastar Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Medroxyprogesterone Acetate
NDC 0548-5400

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension, Extended Release
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Medroxyprogesterone Acetate
NDC 0548-5410

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension, Extended Release
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Medroxyprogesterone Acetate
NDC 0548-5701

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension, Extended Release
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Medroxyprogesterone Acetate
NDC 0548-5711

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension, Extended Release
Route
Intramuscular
Marketing
ANDA
Active Listing

AstraZeneca Pharmaceuticals LP

NDC Product
Human Prescription Drug

Tagrisso
NDC 0310-1349

Generic Name
Osimertinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tagrisso
NDC 0310-1350

Generic Name
Osimertinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Calquence
NDC 0310-3512

Generic Name
Acalabrutinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Truqap
NDC 0310-9500

Generic Name
Capivasertib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Truqap
NDC 0310-9501

Generic Name
Capivasertib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Baxter Healthcare Corporation

NDC Product
Human Prescription Drug

Recothrom
NDC 0338-0322

Generic Name
Thrombin Topical Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Recothrom
NDC 0338-0326

Generic Name
Thrombin Topical Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Recothrom
NDC 0338-0330

Generic Name
Thrombin Topical Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Beutlich Pharmaceuticals LLC

NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0998

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0998

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Beutlich Pharmaceuticals, LLC

NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0220

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic Gel
NDC 0283-0293

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic Gel
NDC 0283-0293

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic Gel
NDC 0283-0293

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0520

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0520

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0520

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0522

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0622

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0871

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0871

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0871

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic Gel
NDC 0283-0886

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic Gel
NDC 0283-0886

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0920

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0920

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-0920

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-1820

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-1820

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Hurricaine Topical Anesthetic
NDC 0283-1820

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental; Oral; Periodontal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Cosette Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Azor
NDC 0713-0870

Generic Name
Amlodipine Besylate And Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Azor
NDC 0713-0871

Generic Name
Amlodipine Besylate And Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Azor
NDC 0713-0872

Generic Name
Amlodipine Besylate And Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Azor
NDC 0713-0873

Generic Name
Amlodipine Besylate And Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

ENDO USA, Inc.

NDC Product
Human Prescription Drug

Posaconazole
NDC 0254-2045

Generic Name
Posaconazole
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Eli Lilly and Company

NDC Product
Human Prescription Drug

Inluriyo
NDC 0002-1717

Generic Name
Imlunestrant
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyvow
NDC 0002-4312

Generic Name
Lasmiditan
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyvow
NDC 0002-4491

Generic Name
Lasmiditan
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

Exeltis USA, Inc.

NDC Product
Human Prescription Drug

Slynd
NDC 0642-7470

Generic Name
Drospirenone
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Galderma Laboratories, L.P.

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Perdiem
NDC 0067-8143

Generic Name
Sennosides, Stimulant Laxative
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Henry Schein Inc.

NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0032

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0033

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0034

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0035

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0036

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0037

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0038

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Benzo-jel
NDC 0404-0039

Generic Name
Benzocaine
Dosage Form
Gel
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc

NDC Product
Human Prescription Drug

Febuxostat
NDC 0054-0413

Generic Name
Febuxostat
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Febuxostat
NDC 0054-0414

Generic Name
Febuxostat
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Alvimopan
NDC 0054-0668

Generic Name
Alvimopan
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Indomethacin
NDC 0054-1950

Generic Name
Indomethacin
Dosage Form
Suppository
Route
Rectal
Marketing
ANDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Clear Lax
NDC 0113-0306

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Clearlax
NDC 0113-1023

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Omeprazole
NDC 0113-1723

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Injoy Constipation Relief
NDC 0113-6900

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

Lannett Company Inc.

NDC Product
Human Prescription Drug

Posaconazole
NDC 0527-2133

Generic Name
Posaconazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Mesalamine
NDC 0527-3012

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

MAJOR PHARMACEUTICALS

NDC Product
Human Prescription Drug

Febuxostat
NDC 0904-7395

Generic Name
Febuxostat
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Febuxostat
NDC 0904-7396

Generic Name
Febuxostat
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Ursodiol
NDC 0904-6890

Generic Name
Ursodiol
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Polyethylene Glycol 3350
NDC 0904-6931

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Posaconazole
NDC 0904-7149

Generic Name
Posaconazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lacosamide
NDC 0904-7244

Generic Name
Lacosamide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lacosamide
NDC 0904-7245

Generic Name
Lacosamide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lacosamide
NDC 0904-7246

Generic Name
Lacosamide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lacosamide
NDC 0904-7247

Generic Name
Lacosamide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0078

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0080

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Janumet Xr
NDC 0006-0081

Generic Name
Sitagliptin And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-0227

Generic Name
Raltegravir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-0473

Generic Name
Raltegravir
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-0477

Generic Name
Raltegravir
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-3080

Generic Name
Raltegravir
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Isentress
NDC 0006-3603

Generic Name
Raltegravir
Dosage Form
Granule, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Steglatro
NDC 0006-5363

Generic Name
Ertugliflozin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Steglatro
NDC 0006-5364

Generic Name
Ertugliflozin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-2224

Generic Name
Posaconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-4324

Generic Name
Posaconazole
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noxafil
NDC 0085-4331

Generic Name
Posaconazole
Dosage Form
Solution
Route
Intravenous
Marketing
NDA
Active Listing

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Imatinib Mesylate
NDC 0378-2245

Generic Name
Imatinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Imatinib Mesylate
NDC 0378-2246

Generic Name
Imatinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

NCS HealthCare of KY, LLC dba Vangard Labs

NDC Product
Human Prescription Drug

Risperidone
NDC 0615-8196

Generic Name
Risperidone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 0615-8197

Generic Name
Risperidone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 0615-8198

Generic Name
Risperidone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 0615-8376

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Divalproex Sodium
NDC 0615-8377

Generic Name
Divalproex Sodium
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metoprolol Tartrate
NDC 0615-8421

Generic Name
Metoprolol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metoprolol Tartrate
NDC 0615-8422

Generic Name
Metoprolol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Metoprolol Tartrate
NDC 0615-8423

Generic Name
Metoprolol
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0615-8498

Generic Name
Levetiracetam
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0615-8499

Generic Name
Levetiracetam
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0615-8500

Generic Name
Levetiracetam
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0615-8501

Generic Name
Levetiracetam
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Famotidine
NDC 0615-8558

Generic Name
Famotidine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Famotidine
NDC 0615-8559

Generic Name
Famotidine
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Mupirocin
NDC 0121-1076

Generic Name
Mupirocin
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing

Padagis US LLC

NDC Product
Human Prescription Drug

Trospium Chloride
NDC 0574-0145

Generic Name
Trospium Chloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Bosulif
NDC 0069-0135

Generic Name
Bosutinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Bosulif
NDC 0069-0136

Generic Name
Bosutinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Bosulif
NDC 0069-0193

Generic Name
Bosutinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Vizimpro
NDC 0069-0197

Generic Name
Dacomitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Velsipity
NDC 0069-0274

Generic Name
Etrasimod
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xeljanz Xr
NDC 0069-0501

Generic Name
Tofacitinib
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xeljanz Xr
NDC 0069-0502

Generic Name
Tofacitinib
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xeljanz
NDC 0069-1001

Generic Name
Tofacitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xeljanz
NDC 0069-1002

Generic Name
Tofacitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Xeljanz
NDC 0069-1029

Generic Name
Tofacitinib
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Vizimpro
NDC 0069-1198

Generic Name
Dacomitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Vizimpro
NDC 0069-2299

Generic Name
Dacomitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Paxlovid
NDC 0069-5045

Generic Name
Nirmatrelvir And Ritonavir
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Paxlovid
NDC 0069-5317

Generic Name
Nirmatrelvir And Ritonavir
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Paxlovid
NDC 0069-5321

Generic Name
Nirmatrelvir And Ritonavir
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Pharmacia & Upjohn Company LLC

NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0274

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0280

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-0306

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-0746

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-3073

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intra-articular; Intralesional; Intramuscular; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-3073

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-medrol
NDC 0009-3475

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intra-articular; Intralesional; Intramuscular; Soft Tissue
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-provera
NDC 0009-7376

Generic Name
Medroxyprogesterone Acetate
Dosage Form
Injection, Suspension
Route
Intramuscular
Marketing
NDA
Active Listing

Rugby Laboratories

NDC Product
Human Otc Drug

Rugby Peg 3350
NDC 0536-1052

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

Sandoz Inc.

NDC Product
Human Prescription Drug

Methylprednisolone Acetate
NDC 0781-3516

Generic Name
Methylprednisolone Acetate
Dosage Form
Injection, Suspension
Route
Intralesional; Intramuscular; Intrasynovial; Soft Tissue
Marketing
ANDA
Active Listing

SpecGx LLC

NDC Product
Human Prescription Drug

Prucalopride
NDC 0406-6301

Generic Name
Prucalopride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prucalopride
NDC 0406-6302

Generic Name
Prucalopride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Posaconazole
NDC 0406-7711

Generic Name
Posaconazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Takeda Pharmaceuticals America, Inc.

NDC Product
Plasma Derivative

Aralast Np
NDC 0944-2814

Generic Name
Alpha-1-proteinase Inhibitor (human)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Aralast Np
NDC 0944-2815

Generic Name
Alpha-1-proteinase Inhibitor (human)
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Recombinate
NDC 0944-2841

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Recombinate
NDC 0944-2842

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing
NDC Product
Plasma Derivative

Recombinate
NDC 0944-2843

Generic Name
Antihemophilic Factor Recombinant
Dosage Form
Kit
Route
N/A
Marketing
BLA
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Mupirocin
NDC 0093-1010

Generic Name
Mupirocin
Dosage Form
Ointment
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sildenafil
NDC 0093-5341

Generic Name
Sildenafil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sildenafil
NDC 0093-5342

Generic Name
Sildenafil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Sildenafil
NDC 0093-5343

Generic Name
Sildenafil
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Losartan Potassium And Hydrochlorothiazide
NDC 0093-7367

Generic Name
Losartan Potassium And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Losartan Potassium And Hydrochlorothiazide
NDC 0093-7368

Generic Name
Losartan Potassium And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Losartan Potassium And Hydrochlorothiazide
NDC 0093-7369

Generic Name
Losartan Potassium And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluvastatin Sodium
NDC 0093-7446

Generic Name
Fluvastatin Sodium
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Glipizide And Metformin Hydrochloride
NDC 0093-7455

Generic Name
Glipizide And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Glipizide And Metformin Hydrochloride
NDC 0093-7456

Generic Name
Glipizide And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Glipizide And Metformin Hydrochloride
NDC 0093-7457

Generic Name
Glipizide And Metformin Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Letrozole
NDC 0093-7620

Generic Name
Letrozole
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Tiopronin
NDC 0093-7909

Generic Name
Tiopronin
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
ANDA
Active Listing

Teva Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Vilazodone Hydrochloride
NDC 0480-2043

Generic Name
Vilazodone Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Vilazodone Hydrochloride
NDC 0480-2044

Generic Name
Vilazodone Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Vilazodone Hydrochloride
NDC 0480-2045

Generic Name
Vilazodone Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fidaxomicin
NDC 0480-2596

Generic Name
Fidaxomicin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lapatinib
NDC 0480-3237

Generic Name
Lapatinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alvaiz
NDC 0480-3273

Generic Name
Eltrombopag
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Alvaiz
NDC 0480-3274

Generic Name
Eltrombopag
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Alvaiz
NDC 0480-3275

Generic Name
Eltrombopag
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Alvaiz
NDC 0480-3276

Generic Name
Eltrombopag
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Dapagliflozin
NDC 0480-3527

Generic Name
Dapagliflozin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dapagliflozin
NDC 0480-3528

Generic Name
Dapagliflozin
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Gefitinib
NDC 0480-4053

Generic Name
Gefitinib
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Mesalamine
NDC 0480-7750

Generic Name
Mesalamine
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Upsher-Smith Laboratories, LLC

NDC Product
Human Prescription Drug

Klor-con
NDC 0245-0835

Generic Name
Potassium Chloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Klor-con
NDC 0245-0836

Generic Name
Potassium Chloride
Dosage Form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing
ANDA
Active Listing

WALGREEN COMPANY

NDC Product
Human Otc Drug

Walgreens
NDC 0363-5260

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

WALGREENS

NDC Product
Human Otc Drug

Ibuprofen
NDC 0363-9611

Generic Name
Ibuprofen
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Ibuprofen
NDC 0363-9612

Generic Name
Ibuprofen
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Omeprazole
NDC 0363-0007

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Smooth Lax
NDC 0363-0306

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Smoothlax
NDC 0363-1323

Generic Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

Walgreens

NDC Product
Human Otc Drug

Pm Toothache Relief
NDC 0363-1623

Generic Name
Benzocaine
Dosage Form
Paste
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Omeprazole
NDC 0363-9510

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

Walgreens Company

NDC Product
Human Otc Drug

Omeprazole
NDC 0363-1607

Generic Name
Omeprazole
Dosage Form
Tablet, Delayed Release
Route
Oral
Marketing
ANDA
Active Listing

External Clinical & Regulatory Resources

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