LACTOSE MONOHYDRATE
UNII EWQ57Q8I5X

Substance Identification & Data

This profile provides standardized clinical and technical data for Lactose Monohydrate, uniquely identified by the FDA Unique Ingredient Identifier (UNII) EWQ57Q8I5X.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 64044-51-5 and the RxNorm Concept ID (RxCUI) 1305527. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
EWQ57Q8I5X
CAS Registry Number
64044-51-5
RxNorm Concept ID
1305527

Detailed Substance Profile

Preferred Name
LACTOSE MONOHYDRATE
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
EWQ57Q8I5X
The specific atomic composition represented as a molecular structure string.
InChIKey
C12H22O11.H2O
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
WSVLPVUVIUVCRA-KPKNDVKVSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C76719
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
104938
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[C@]1([C@@H]([C@H]([C@@H](O)[C@H](O1)CO)O)O)(O[C@H]2[C@@H]([C@@H](O)[C@H](O[C@@H]2CO)O)O)[H].O

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Lactose Monohydrate. 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.

Common Names & Synonyms

.ALPHA.-D-GLUCOPYRANOSE, 4-O-.BETA.-D-GALACTOPYRANOSYL-, MONOHYDRATE
D-GLUCOSE, 4-O-.BETA.-D-GALACTOPYRANOSYL-, MONOHYDRATE
LACTOSE HYDRATE
LACTOSE HYDRATE [JAN]
LACTOSE HYDROUS
LACTOSE MONOHYDRATE
LACTOSE MONOHYDRATE [EP MONOGRAPH]
LACTOSE MONOHYDRATE [II]
LACTOSE MONOHYDRATE [USP-RS]
LACTOSE MONOHYDRATE [WHO-DD]
LACTOSE MONOHYDRATE [WHO-IP]
LACTOSE, HYDROUS
LACTOSE, HYDROUS [II]
LACTOSE, MONOHYDRATE
LACTOSUM, MONOHYDRATE [WHO-IP LATIN]
PHARMATOSE DCL 11
PHARMATOSE DCL II
PHARMATOSE DCL II [II]

Brand / Trade Names

HMS
LACTOCHEM
LACTOHALE
LACTOPRESS
LACTOPRESS GRANULATED
LACTOPRESS SPRAY DRIED
LACTOSE FASTFLO 316
PHARMATOSE
RESPITOSE
SUPERTAB 11SD
SUPERTAB 11SD NZ
SUPERTAB 14SD
SUPERTAB 30GR
SUPERTAB 50 ODT
WYNDALE
WYNHALE

Technical Codes

NSC-760401

NDC Products Containing LACTOSE MONOHYDRATE

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. 15
→ E.R. Squibb & Sons, L.L.C. 17
→ Eli Lilly and Company 10
→ Haleon US Holdings LLC 2
→ Hikma Pharmaceuticals USA Inc 2
→ Hikma Pharmaceuticals USA Inc. 39
→ Hikma Pharmaceuticals USA, Inc. 16
→ Merck Sharp & Dohme LLC 22
→ Novartis Pharmaceuticals Corporation 20
→ PFIZER LABORATORIES DIV PFIZER INC 1
→ Pfizer Laboratories Div Pfizer Inc 26
→ Pharmacia & Upjohn Company LLC 7
→ Roerig 1
→ Sanofi-Aventis U.S. LLC 8
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 14

AbbVie Inc.

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

Synthroid
NDC 0074-3727

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

Synthroid
NDC 0074-4341

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

Synthroid
NDC 0074-4552

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

Synthroid
NDC 0074-5182

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

Synthroid
NDC 0074-6594

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

Synthroid
NDC 0074-6624

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

Synthroid
NDC 0074-7068

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

Synthroid
NDC 0074-7069

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

Synthroid
NDC 0074-7070

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

Synthroid
NDC 0074-7148

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

Synthroid
NDC 0074-7149

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

Synthroid
NDC 0074-9296

Generic Name
Levothyroxine Sodium
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing

E.R. Squibb & Sons, L.L.C.

NDC Product
Human Prescription Drug

Cobenfy
NDC 0003-0050

Generic Name
Xanomeline And Trospium Chloride
Dosage Form
Capsule, Coated Pellets
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cobenfy
NDC 0003-0125

Generic Name
Xanomeline And Trospium Chloride
Dosage Form
Capsule, Coated Pellets
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sprycel
NDC 0003-0524

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

Sprycel
NDC 0003-0527

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

Sprycel
NDC 0003-0528

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

Sprycel
NDC 0003-0852

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

Sprycel
NDC 0003-0855

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

Sprycel
NDC 0003-0857

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

Eliquis
NDC 0003-0893

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

Eliquis
NDC 0003-0894

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

Baraclude
NDC 0003-1611

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

Baraclude
NDC 0003-1612

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

Baraclude
NDC 0003-1614

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

Reyataz
NDC 0003-3622

Generic Name
Atazanavir
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyataz
NDC 0003-3631

Generic Name
Atazanavir
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Reyataz
NDC 0003-3638

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

Eliquis 30-day Starter Pack
NDC 0003-3764

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

Eli Lilly and Company

NDC Product
Human Prescription Drug

Evista
NDC 0002-4184

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

Cialis
NDC 0002-4462

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

Cialis
NDC 0002-4463

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

Cialis
NDC 0002-4464

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

Verzenio
NDC 0002-4483

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

Verzenio
NDC 0002-4815

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

Verzenio
NDC 0002-5337

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

Verzenio
NDC 0002-6216

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

Jaypirca
NDC 0002-6902

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

Jaypirca
NDC 0002-7026

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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Excedrin Extra Strength Geltabs
NDC 0067-2021

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine Geltabs
NDC 0067-2035

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
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

Prednisone
NDC 0054-0017

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

Prednisone
NDC 0054-0018

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

Prednisone
NDC 0054-0019

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

Buprenorphine
NDC 0054-0176

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine
NDC 0054-0177

Generic Name
Buprenorphine
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Irbesartan And Hydrochlorothiazide
NDC 0054-0254

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

Irbesartan And Hydrochlorothiazide
NDC 0054-0255

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

Fluticasone Propionate And Salmeterol
NDC 0054-0326

Generic Name
Fluticasone Propionate And Salmeterol
Dosage Form
Powder
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Fluticasone Propionate And Salmeterol
NDC 0054-0327

Generic Name
Fluticasone Propionate And Salmeterol
Dosage Form
Powder
Route
Respiratory (inhalation)
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cevimeline Hydrochloride
NDC 0054-0334

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

Rufinamide
NDC 0054-0425

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

Rufinamide
NDC 0054-0426

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

Dicyclomine Hydrochloride
NDC 0054-0748

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

Tapentadol
NDC 0054-0942

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0943

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Tapentadol
NDC 0054-0945

Generic Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Furosemide
NDC 0054-3294

Generic Name
Furosemide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Furosemide
NDC 0054-3298

Generic Name
Furosemide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Meperidine Hydrochloride
NDC 0054-3545

Generic Name
Meperidine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone Intensol
NDC 0054-3721

Generic Name
Prednisone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Prednisone
NDC 0054-3722

Generic Name
Prednisone
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Furosemide
NDC 0054-4297

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

Furosemide
NDC 0054-4299

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

Furosemide
NDC 0054-4301

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

Mercaptopurine
NDC 0054-4581

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

Prednisone
NDC 0054-4728

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

Prednisone
NDC 0054-4741

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

Prednisone
NDC 0054-4742

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

Furosemide
NDC 0054-8297

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

Furosemide
NDC 0054-8299

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

Furosemide
NDC 0054-8301

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

Prednisone
NDC 0054-8724

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

Prednisone
NDC 0054-8739

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

Prednisone
NDC 0054-8740

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

Prednisone
NDC 0054-9817

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

Prednisone
NDC 0054-9818

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

Prednisone
NDC 0054-9828

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

Hikma Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Dexamethasone Intensol
NDC 0054-3176

Generic Name
Dexamethasone Intensol
Dosage Form
Solution, Concentrate
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-3177

Generic Name
Dexamethasone
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dexamethasone
NDC 0054-4179

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

Dexamethasone
NDC 0054-4180

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

Dexamethasone
NDC 0054-4181

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

Dexamethasone
NDC 0054-4182

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

Dexamethasone
NDC 0054-4183

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

Dexamethasone
NDC 0054-4184

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

Dexamethasone
NDC 0054-4186

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

Dexamethasone
NDC 0054-8174

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

Dexamethasone
NDC 0054-8175

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

Dexamethasone
NDC 0054-8176

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

Dexamethasone
NDC 0054-8179

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

Dexamethasone
NDC 0054-8180

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

Dexamethasone
NDC 0054-8181

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

Dexamethasone
NDC 0054-8183

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

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Belsomra
NDC 0006-0005

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

Belsomra
NDC 0006-0033

Generic Name
Suvorexant
Dosage Form
Tablet, Film Coated
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

Belsomra
NDC 0006-0325

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

Belsomra
NDC 0006-0335

Generic Name
Suvorexant
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

Pifeltro
NDC 0006-3069

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

Zepatier
NDC 0006-3074

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

Prevymis
NDC 0006-3075

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

Prevymis
NDC 0006-3076

Generic Name
Letermovir
Dosage Form
Tablet, Film Coated
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

Prevymis
NDC 0006-5003

Generic Name
Letermovir
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prevymis
NDC 0006-5004

Generic Name
Letermovir
Dosage Form
Injection, Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Delstrigo
NDC 0006-5007

Generic Name
Doravirine, Lamivudine, And Tenofovir Disoproxil Fumarate
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Verquvo
NDC 0006-5028

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

Verquvo
NDC 0006-5029

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

Verquvo
NDC 0006-5030

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

Idvynso
NDC 0006-5092

Generic Name
Doravirine, Islatravir
Dosage Form
Tablet, Film Coated
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

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Femara
NDC 0078-0249

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

Zortress
NDC 0078-0414

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

Zortress
NDC 0078-0415

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

Zortress
NDC 0078-0417

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

Exjade
NDC 0078-0468

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

Exjade
NDC 0078-0469

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

Exjade
NDC 0078-0470

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

Tasigna
NDC 0078-0526

Generic Name
Nilotinib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Afinitor
NDC 0078-0566

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

Afinitor
NDC 0078-0567

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

Tasigna
NDC 0078-0592

Generic Name
Nilotinib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Afinitor
NDC 0078-0594

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

Afinitor
NDC 0078-0620

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

Afinitor Disperz
NDC 0078-0626

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

Afinitor Disperz
NDC 0078-0627

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

Afinitor Disperz
NDC 0078-0628

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

Jadenu
NDC 0078-0655

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

Jadenu
NDC 0078-0656

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

Jadenu
NDC 0078-0713

Generic Name
Deferasirox
Dosage Form
Granule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Jadenu
NDC 0078-0720

Generic Name
Deferasirox
Dosage Form
Granule
Route
Oral
Marketing
NDA
Active Listing

PFIZER LABORATORIES DIV PFIZER INC

NDC Product
Human Prescription Drug

Revatio
NDC 0069-4190

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Inlyta
NDC 0069-0145

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

Inlyta
NDC 0069-0151

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

Ibrance
NDC 0069-0187

Generic Name
Palbociclib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Ibrance
NDC 0069-0188

Generic Name
Palbociclib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Ibrance
NDC 0069-0189

Generic Name
Palbociclib
Dosage Form
Capsule
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

Lorbrena
NDC 0069-0227

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

Lorbrena
NDC 0069-0231

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

Cibinqo
NDC 0069-0235

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

Toviaz
NDC 0069-0242

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

Toviaz
NDC 0069-0244

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

Daurismo
NDC 0069-0298

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

Litfulo
NDC 0069-0334

Generic Name
Ritlecitinib
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Cibinqo
NDC 0069-0335

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

Cibinqo
NDC 0069-0435

Generic Name
Abrocitinib
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

Daurismo
NDC 0069-1531

Generic Name
Glasdegib
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

Solu-medrol
NDC 0009-0003

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0018

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0039

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0039

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0047

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0047

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Solu-medrol
NDC 0009-0850

Generic Name
Methylprednisolone Sodium Succinate
Dosage Form
Injection, Powder, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing

Roerig

NDC Product
Human Prescription Drug

Vfend
NDC 0049-3160

Generic Name
Voriconazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
NDA
Active Listing

Sanofi-Aventis U.S. LLC

NDC Product
Human Prescription Drug

Plavix
NDC 0024-1171

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

Plavix
NDC 0024-1332

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

Multaq
NDC 0024-4142

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

Fexinidazole
NDC 0024-4512

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

Avapro
NDC 0024-5851

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

Avapro
NDC 0024-5852

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

Avalide
NDC 0024-5855

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

Avalide
NDC 0024-5856

Generic Name
Irbesartan And Hydrochlorothiazide
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Duavee
NDC 0008-1123

Generic Name
Conjugated Estrogens/bazedoxifene
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tygacil
NDC 0008-4990

Generic Name
Tigecycline
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tygacil
NDC 0008-4994

Generic Name
Tigecycline
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premarin
NDC 0046-0749

Generic Name
Conjugated Estrogens
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intramuscular; Intravenous
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premarin
NDC 0046-1100

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

Premarin
NDC 0046-1101

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

Premarin
NDC 0046-1102

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

Premarin
NDC 0046-1103

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

Premarin
NDC 0046-1104

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

Prempro
NDC 0046-1105

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1106

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1107

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Prempro
NDC 0046-1108

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Tablet, Sugar Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Premphase
NDC 0046-2575

Generic Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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