SORBITOL
UNII 506T60A25R

Substance Identification & Data

This profile provides standardized clinical and technical data for Sorbitol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 506T60A25R.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 50-70-4 and the RxNorm Concept ID (RxCUI) 9945. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
506T60A25R
CAS Registry Number
50-70-4
RxNorm Concept ID
9945

Detailed Substance Profile

Preferred Name
SORBITOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
506T60A25R
The specific atomic composition represented as a molecular structure string.
InChIKey
C6H14O6
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
FBPFZTCFMRRESA-JGWLITMVSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C29462
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
5780
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@H]([C@@H]([C@H](O)CO)O)([C@@H](O)CO)O

Synonyms and Nomenclature

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

SORBITOL

Common Names & Synonyms

D-GLUCITOL
D-GLUCITOL SYRUP
D-SORBITOL
D-SORBITOL [FHFI]
D-SORBITOL [JAN]
E-420(I)
GLUCITOL, D-
INS NO.420(I)
INS-420(I)
ISOMALT IMPURITY C [EP IMPURITY]
ISOMALT IMPURITY, SORBITOL- [USP IMPURITY]
LACTITOL MONOHYDRATE IMPURITY E [EP IMPURITY]
MALTITOL IMPURITY A [EP IMPURITY]
SORBITOL (E420)
SORBITOL [EP MONOGRAPH]
SORBITOL [FCC]
SORBITOL [HSDB]
SORBITOL [II]
SORBITOL [MART.]
SORBITOL [MI]
SORBITOL [ORANGE BOOK]
SORBITOL [USP]
SORBITOL [USP-RS]
SORBITOL [VANDF]
SORBITOL [WHO-DD]
SORBITOL SOLUTIONS
SORBITOL-MANNITOL COMPONENT SORBITOL

Brand / Trade Names

NEOSORB P 60W

Systematic Nomenclature

1,2,3,4,5,6-HEXANEHEXOL
SORBIT

Technical Codes

7B5697N
E 420
FEMA NO. 3029
NSC-25944

NDC Products Containing SORBITOL

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.
→ Alcon Laboratories, Inc. 15
→ Allergan, Inc. 1
→ Genentech, Inc. 2
→ Haleon US Holdings LLC 27
→ Hikma Pharmaceuticals USA 2
→ Hikma Pharmaceuticals USA Inc. 23
→ Hikma Pharmaceuticals USA, Inc. 8
→ Hikma Pharmceuticals USA Inc. 1
→ L Perrigo Company 1
→ L. Perrigo Company 43
→ Merck Sharp & Dohme LLC 6
→ Novartis Pharmaceuticals Corporation 9
→ PAI Holdings, LLC 5
→ PAI Holdings, LLC dba PAI Pharma 28
→ Parke-Davis Div of Pfizer Inc 1
→ Pfizer Laboratories Div Pfizer Inc 18
→ Pharmaceutical Associates, Inc. 4
→ Teva Pharmaceuticals USA Inc. 1
→ Teva Pharmaceuticals USA, Inc. 4
→ Xttrium Laboratories, Inc 1

Alcon Laboratories, Inc.

NDC Product
Human Otc Drug

Systane
NDC 0065-0454

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Gel
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane
NDC 0065-0474

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

Systane Complete
NDC 0065-0481

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra
NDC 0065-1431

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra
NDC 0065-1432

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Balance
NDC 0065-1433

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Day And Night Value Pack
NDC 0065-1502

Generic Name
Polyethylene Glycol 400, Propylene Glycol 0.3%
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Ultra Preservative Free
NDC 0065-1507

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-1509

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Hydration Pf Preservative Free
NDC 0065-1510

Generic Name
Polyethylene Glycol 400 And Propylene Glycol
Dosage Form
Solution/ Drops
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-1530

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Complete Pf
NDC 0065-2509

Generic Name
Propylene Glycol Emulsion
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Systane Pro Pf
NDC 0065-3290

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Genteal Tears Severe
NDC 0065-8064

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

Systane Pro Pf
NDC 0065-9308

Generic Name
Propylene Glycol
Dosage Form
Emulsion
Route
Ophthalmic
Marketing
OTC MONOGRAPH DRUG
Active Listing

Allergan, Inc.

NDC Product
Human Prescription Drug

Taytulla
NDC 0023-5862

Generic Name
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fum...
Dosage Form
Kit
Route
N/A
Marketing
NDA
Active Listing

Genentech, Inc.

NDC Product
Human Prescription Drug

Cellcept
NDC 0004-0261

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

Tamiflu
NDC 0004-0822

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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Childrens Robitussin Cough And Cold Cf
NDC 0031-8716

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrin...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Bulk Ingredient

NDC 0031-8729

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hy...
Dosage Form
Syrup
Route
N/A
Marketing
EXPORT ONLY
Active Listing
NDC Product
Human Otc Drug

Robitussin Peak Cold Multi-symptom Cold
NDC 0031-8742

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrin...
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Long-acting Coughgels
NDC 0031-8743

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Direct Cough
NDC 0031-9302

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Long-acting Cough Soft Chews
NDC 0031-9310

Generic Name
Dextromethorphan Hydrobromide
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Robitussin Nighttime Cough Dm Soft Chews
NDC 0031-9311

Generic Name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Severe Cold Relief Soft Chews
NDC 0067-0111

Generic Name
Acetaminophen, Dextromethorphan Hbr
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0118

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Total Relief Maximum Strength
NDC 0067-0119

Generic Name
Calcium Carbonate, Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gas-x Extra Strength Softgels
NDC 0067-6275

Generic Name
Simethicone
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA

NDC Product
Human Prescription Drug

Methadone Hydrochloride
NDC 0054-0391

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

Methadone Hydrochloride
NDC 0054-0392

Generic Name
Methadone Hydrochloride
Dosage Form
Concentrate
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Lithium Carbonate
NDC 0054-0021

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

Digoxin
NDC 0054-0057

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

Citalopram
NDC 0054-0062

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

Hydromorphone Hydrochloride
NDC 0054-0386

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

Posaconazole
NDC 0054-0449

Generic Name
Posaconazole
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Icosapent Ethyl
NDC 0054-0508

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

Morphine Sulfate
NDC 0054-0517

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

Rufinamide
NDC 0054-0528

Generic Name
Rufinamide
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Dicyclomine Hydrochloride
NDC 0054-0622

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

Aminocaproic Acid
NDC 0054-1100

Generic Name
Aminocaproic Acid
Dosage Form
Syrup
Route
Oral
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Diazepam Intensol
NDC 0054-3185

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

Diazepam
NDC 0054-3188

Generic Name
Diazepam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
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

Methadone Hydrochloride
NDC 0054-3555

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

Methadone Hydrochloride
NDC 0054-3556

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

Midazolam Hydrochloride
NDC 0054-3566

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

Naproxen
NDC 0054-3630

Generic Name
Naproxen
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Propranolol Hydrochloride
NDC 0054-3727

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

Propranolol Hydrochloride
NDC 0054-3730

Generic Name
Propranolol Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA, Inc.

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 0054-8174

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

Hikma Pharmceuticals USA Inc.

NDC Product
Human Prescription Drug

Oxycodone Hydrochloride
NDC 0054-0390

Generic Name
Oxycodone Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

L Perrigo Company

NDC Product
Human Otc Drug

Mederma Pm
NDC 0113-4124

Generic Name
Dimethicone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Severe Nighttime
NDC 0113-0019

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, P...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0029

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0053

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Ibuprofen Infants
NDC 0113-0057

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

Good Sense Lansoprazole
NDC 0113-0116

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

Good Sense Pain And Fever
NDC 0113-0161

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0170

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine Mint
NDC 0113-0206

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Allergy
NDC 0113-0379

Generic Name
Diphenhydramine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Zephrex D
NDC 0113-0401

Generic Name
Pseudoephedrine Hydrochloride
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0422

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0456

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Stool Softener
NDC 0113-0486

Generic Name
Docusate Sodium
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Omeprazole
NDC 0113-0520

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

Good Sense Nicotine
NDC 0113-0532

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Ibuprofen
NDC 0113-0685

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

Good Sense Severe Nighttime Cold And Flu
NDC 0113-0763

Generic Name
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, P...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-0854

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Tussin Dm Max
NDC 0113-0927

Generic Name
Dextromethorphan Hbr, Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain And Fever Infants
NDC 0113-0946

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense All Day Allergy
NDC 0113-0981

Generic Name
Cetirizine Hydrochloride
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Childrens Cold And Cough
NDC 0113-0987

Generic Name
Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Daytime
NDC 0113-0994

Generic Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-1352

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Tussin Dm
NDC 0113-1725

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Day Time Cold And Flu
NDC 0113-2299

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, P...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Night Time Cold And Flu
NDC 0113-2501

Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Suc...
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-4111

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Ibuprofen
NDC 0113-4501

Generic Name
Ibuprofen
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-6020

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-8100

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-8600

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Pain And Fever
NDC 0113-8959

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Merck Sharp & Dohme LLC

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
Vaccine

Proquad
NDC 0006-4171

Generic Name
Measles, Mumps, Rubella And Varicella Virus Vaccine Live
Dosage Form
Injection, Powder, Lyophilized, For Suspension
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Vaccine

M-m-r Ii
NDC 0006-4681

Generic Name
Measles, Mumps, And Rubella Virus Vaccine Live
Dosage Form
Injection, Powder, Lyophilized, For Suspension
Route
Intramuscular; Subcutaneous
Marketing
BLA
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Sandimmune
NDC 0078-0109

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

Sandimmune
NDC 0078-0240

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sandimmune
NDC 0078-0241

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Trileptal
NDC 0078-0357

Generic Name
Oxcarbazepine
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol
NDC 0078-0508

Generic Name
Carbamazepine
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Tegretol
NDC 0078-0509

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

Tegretol Xr
NDC 0078-0510

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

Tegretol Xr
NDC 0078-0511

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

Tegretol Xr
NDC 0078-0512

Generic Name
Carbamazepine
Dosage Form
Tablet, Extended Release
Route
Oral
Marketing
NDA
Active Listing

PAI Holdings, LLC

NDC Product
Human Otc Drug

Milk Of Magnesia
NDC 0121-0431

Generic Name
Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-0775

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-1550

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mag-al Liquid
NDC 0121-1760

Generic Name
Aluminum Hydroxide And Magnesium Hydroxide
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Guaifenesin And Codeine Phosphate
NDC 0121-1775

Generic Name
Guaifenesin And Codeine Phosphate
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Metoclopramide
NDC 0121-0576

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

Amantadine Hydrochloride
NDC 0121-0646

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

Acetaminophen
NDC 0121-0657

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Trihexyphenidyl Hydrochloride
NDC 0121-0658

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

Valproic Acid
NDC 0121-0675

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

Potassium Citrate And Citric Acid
NDC 0121-0676

Generic Name
Potassium Citrate And Citric Acid Monohydrate
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Tricitrates
NDC 0121-0677

Generic Name
Potassium Citrate, Sodium Citrate, And Citric Acid Monohydra...
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Nortriptyline Hydrochloride
NDC 0121-0678

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

Calcium Carbonate
NDC 0121-0766

Generic Name
Calcium Carbonate
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Oxycodone Hydrochloride
NDC 0121-0827

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

Diphenhydramine Hcl
NDC 0121-0865

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Morphine Sulfate
NDC 0121-0904

Generic Name
Morphine Sulfate
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Lidocaine Pain Relief
NDC 0121-0970

Generic Name
Lidocaine Pain Relief
Dosage Form
Patch
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Sucralfate
NDC 0121-0974

Generic Name
Sucralfate
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cimetidine Hydrochloride
NDC 0121-1025

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

Acetaminophen
NDC 0121-1047

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-1314

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Valproic Acid
NDC 0121-1350

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

Metoclopramide
NDC 0121-1576

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

Diphenhydramine Hcl
NDC 0121-1730

Generic Name
Diphenhydramine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mag-al Plus
NDC 0121-1761

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mag-al Plus Xs
NDC 0121-1762

Generic Name
Aluminum Hydroxide, Magnesium Hydroxide, And Dimethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Acetaminophen
NDC 0121-1781

Generic Name
Acetaminophen
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-1971

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acetaminophen
NDC 0121-2094

Generic Name
Acetaminophen
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Zarontin
NDC 0071-0237

Generic Name
Ethosuximide
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Lomotil
NDC 0025-0061

Generic Name
Diphenoxylate Hydrochloride And Atropine Sulfate
Dosage Form
Tablet
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Synarel
NDC 0025-0166

Generic Name
Nafarelin Acetate
Dosage Form
Spray, Metered
Route
Nasal
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0252

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0291

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0292

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0293

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nivestym
NDC 0069-0294

Generic Name
Filgrastim-aafi
Dosage Form
Injection, Solution
Route
Intravenous; Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Nyvepria
NDC 0069-0324

Generic Name
Pegfilgrastim-apgf
Dosage Form
Injection, Solution
Route
Subcutaneous
Marketing
BLA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0353

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0454

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
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

Talzenna
NDC 0069-0546

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0655

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Talzenna
NDC 0069-0757

Generic Name
Talazoparib
Dosage Form
Capsule, Liquid Filled
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

Vyndamax
NDC 0069-8730

Generic Name
Tafamidis
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
NDA
Active Listing

Pharmaceutical Associates, Inc.

NDC Product
Human Prescription Drug

Sodium Citrate And Citric Acid
NDC 0121-0595

Generic Name
Sodium Citrate And Citric Acid Monohydrate
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Diazepam
NDC 0121-0905

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

Propranolol Hydrochloride
NDC 0121-0908

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

Sodium Citrate And Citric Acid
NDC 0121-1190

Generic Name
Sodium Citrate And Citric Acid Monohydrate
Dosage Form
Solution
Route
Oral
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Teva Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Diclofenac Epolamine
NDC 0093-3727

Generic Name
Diclofenac Epolamine
Dosage Form
System
Route
Topical
Marketing
NDA AUTHORIZED GENERIC
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Oseltamivir Phosphate
NDC 0093-8180

Generic Name
Oseltamivir Phosphate
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cyclosporine Modified
NDC 0093-9018

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cyclosporine Modified
NDC 0093-9019

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cyclosporine Modified
NDC 0093-9020

Generic Name
Cyclosporine
Dosage Form
Capsule, Liquid Filled
Route
Oral
Marketing
ANDA
Active Listing

Xttrium Laboratories, Inc

NDC Product
Human Prescription Drug

Amantadine
NDC 0116-4010

Generic Name
Amantadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

External Clinical & Regulatory Resources

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