METHYLPARABEN
UNII A2I8C7HI9T

Substance Identification & Data

This profile provides standardized clinical and technical data for Methylparaben, uniquely identified by the FDA Unique Ingredient Identifier (UNII) A2I8C7HI9T.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 99-76-3 and the RxNorm Concept ID (RxCUI) 29903. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
A2I8C7HI9T
CAS Registry Number
99-76-3
RxNorm Concept ID
29903

Detailed Substance Profile

Preferred Name
METHYLPARABEN
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
A2I8C7HI9T
The specific atomic composition represented as a molecular structure string.
InChIKey
C8H8O3
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
LXCFILQKKLGQFO-UHFFFAOYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C76720
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
7456
Unique identification number in the NCBI database of chemical substances.
USAN ID
Y-26
Identifier assigned by the United States Adopted Names Council.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
COC(=O)c1ccc(cc1)O

Synonyms and Nomenclature

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

METHYLPARABEN

Common Names & Synonyms

BENZOIC ACID, 4-HYDROXY-, METHYL ESTER
KILLITOL
METHYL HYDROXYBENZOATE [MART.]
METHYL HYDROXYBENZOATE [WHO-IP]
METHYL PARABEN
METHYL PARABEN (E218)
METHYL PARABEN [VANDF]
METHYL PARAHYDROXYBENZOATE [EP MONOGRAPH]
METHYL PARAHYDROXYBENZOATE [JAN]
METHYL P-HYDROXYBENZOATE [FHFI]
METHYL P-OXYBENZOATE
METHYL SALICYLATE IMPURITY C [EP IMPURITY]
METHYLIS HYDROXYBENZOAS [WHO-IP LATIN]
METHYLPARABEN [FCC]
METHYLPARABEN [HSDB]
METHYLPARABEN [II]
METHYLPARABEN [MI]
METHYLPARABEN [USAN]
METHYLPARABEN [USP-RS]
METHYLPARABEN [VANDF]
METHYLPARABEN [WHO-DD]
METHYLPARABEN E218
MOLDEX
P-HYDROXYBENZOIC METHYL ESTER
PRESERVAL M
PROPYL HYDROXYBENZOATE IMPURITY B [EP IMPURITY]
TEGOSEPT M

Systematic Nomenclature

METHYL 4-HYDROXYBENZOATE
METHYL HYDROXYBENZOATE
METHYL PARAHYDROXYBENZOATE

Technical Codes

E-218
FEMA NO. 2710
INS NO.218
INS-218
NSC-3827
NSC-406127

NDC Products Containing METHYLPARABEN

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.
→ Actavis Pharma, Inc. 6
→ Allergan, Inc. 1
→ BF ASCHER AND CO INC 1
→ Bausch Health US LLC 4
→ Bausch Health US, LLC 9
→ Bayer HealthCare LLC. 7
→ Bracco Diagnostics Inc 1
→ C.B. Fleet Company, Inc. 3
→ E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 4
→ E.R. Squibb & Sons, L.L.C. 1
→ Galderma Laboratories, L.P. 3
→ Genentech, Inc. 1
→ Haleon US Holdings LLC 21
→ Hikma Pharmaceuticals USA Inc. 34
→ Hikma Pharmaceuticals USA, Inc. 8
→ L. Perrigo Company 8
→ Merck Sharp & Dohme LLC 1
→ Merz Pharmaceuticals, LLC 1
→ Mission Pharmacal Company 5
→ Novartis Pharmaceuticals Corporation 1
→ PAI Holdings, LLC 1
→ PAI Holdings, LLC dba PAI Pharma 40
→ Par Health USA, LLC 1
→ Parke-Davis Div of Pfizer Inc 1
→ Pharmaceutical Associates, Inc. 3
→ Pharmacia & Upjohn Company LLC 6
→ Teva Pharmaceuticals USA Inc. 1
→ Teva Pharmaceuticals USA, Inc. 11
→ Trividia Manufacturing Solutions, Inc 2
→ UCB, Inc. 1
→ Viatris Specialty LLC 4
→ West-Ward Pharmaceuticals Corp 2
→ Xttrium Laboratories Inc. 1
→ Xttrium Laboratories, Inc 2
→ Xttrium Laboratories, Inc. 4

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Oxazepam
NDC 0228-2067

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0228-2067

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

NDC 0228-2069

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing
NDC Product
Human Prescription Drug

Oxazepam
NDC 0228-2069

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

Oxazepam
NDC 0228-2073

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Drug For Further Processing

NDC 0228-2073

Generic Name
Oxazepam
Dosage Form
Capsule, Gelatin Coated
Route
N/A
Marketing
DRUG FOR FURTHER PROCESSING
Active Listing

Allergan, Inc.

NDC Product
Human Prescription Drug

Aczone
NDC 0023-3670

Generic Name
Dapsone
Dosage Form
Gel
Route
Topical
Marketing
NDA
Active Listing

BF ASCHER AND CO INC

NDC Product
Human Otc Drug

Itch X
NDC 0225-0495

Generic Name
Benzyl Alcohol/pramoxine Hydrochloride
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bausch Health US LLC

NDC Product
Human Prescription Drug

Cardizem
NDC 0187-0771

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

Cardizem
NDC 0187-0772

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

Cardizem
NDC 0187-0792

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

Renova
NDC 0187-5150

Generic Name
Tretinoin
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing

Bausch Health US, LLC

NDC Product
Human Prescription Drug

Bryhali
NDC 0187-0002

Generic Name
Halobetasol Propionate
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Altreno
NDC 0187-0005

Generic Name
Tretinoin
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Duobrii
NDC 0187-0653

Generic Name
Halobetasol Propionate And Tazarotene
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Arazlo
NDC 0187-2098

Generic Name
Tazarotene
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Efudex
NDC 0187-3204

Generic Name
Fluorouracil
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Klaron
NDC 0187-5198

Generic Name
Sulfacetamide Sodium
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Noritate
NDC 0187-5202

Generic Name
Metronidazole
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Caladryl
NDC 0187-5465

Generic Name
Ferric Oxide Red, Zinc Oxide, And Pramoxine Hydrochloride
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Caladryl Clear
NDC 0187-5466

Generic Name
Pramoxine Hydrochloride And Zinc Acetate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bayer HealthCare LLC.

NDC Product
Human Otc Drug

Alka-seltzer Kids Tummy Reliefchews
NDC 0280-0051

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

Alka-seltzer Heartburn Reliefchews
NDC 0280-0221

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bracco Diagnostics Inc

NDC Product
Human Prescription Drug

Choletec
NDC 0270-0083

Generic Name
Mebrofenin
Dosage Form
Injection, Powder, Lyophilized, For Solution
Route
Intravenous
Marketing
NDA
Active Listing

C.B. Fleet Company, Inc.

NDC Product
Human Otc Drug

Pedia-lax
NDC 0132-0113

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

Fleet
NDC 0132-0401

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

Fleet
NDC 0132-0703

Generic Name
Bisacodyl
Dosage Form
Enema
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0201

Generic Name
Clindamycin Phosphate
Dosage Form
Solution
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0202

Generic Name
Clindamycin Phosphate
Dosage Form
Gel
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clindamycin Phosphate
NDC 0168-0203

Generic Name
Clindamycin Phosphate
Dosage Form
Lotion
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Adapalene
NDC 0168-0424

Generic Name
Adapalene
Dosage Form
Cream
Route
Topical
Marketing
ANDA
Active Listing

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

NDC Product
Human Prescription Drug

Baraclude
NDC 0003-1614

Generic Name
Entecavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

Galderma Laboratories, L.P.

NDC Product
Human Prescription Drug

Soolantra
NDC 0299-3823

Generic Name
Ivermectin
Dosage Form
Cream
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Cetaphil Cracked Skin Repair
NDC 0299-4114

Generic Name
Dimethicone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Differin
NDC 0299-4910

Generic Name
Adapalene
Dosage Form
Gel
Route
Topical
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

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8655

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8753

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8754

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Robitussin 12 Hour Cough Relief
NDC 0031-8755

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension, Extended Release
Route
Oral
Marketing
ANDA
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

Perdiem
NDC 0067-8143

Generic Name
Sennosides, Stimulant Laxative
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0183

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

Tums Chewy Bites Berry Shake
NDC 0135-0184

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

Tums Chewy Bites Raspberry Lemonade
NDC 0135-0188

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

Abreva Rapid Pain Relief
NDC 0135-0400

Generic Name
Glycerin, Lidocaine
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Tums Chewy Bites
NDC 0135-0606

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

Tums Chewy Bites
NDC 0135-0618

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

Tums Chewy Bites With Gas Relief
NDC 0135-0624

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

Tums Chewy Bites Mixed Fruit
NDC 0135-0641

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

Tums Chewy Bites Orange And Cream Es
NDC 0135-0642

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hikma Pharmaceuticals USA Inc.

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

Galantamine Hydrobromide
NDC 0054-0137

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

Alendronate Sodium
NDC 0054-0282

Generic Name
Alendronate Sodium
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

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

Lidocaine Viscous
NDC 0054-3500

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

Lidocaine Hydrochloride
NDC 0054-3505

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Topical
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
NDC Product
Human Prescription Drug

Gentamicin
NDC 0143-9128

Generic Name
Gentamicin
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Gentamicin
NDC 0143-9129

Generic Name
Gentamicin
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9319

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9320

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupivacaine Hydrochloride
NDC 0143-9328

Generic Name
Bupivacaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Bupivacaine Hydrochloride
NDC 0143-9329

Generic Name
Bupivacaine Hydrochloride
Dosage Form
Injection, Solution
Route
Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Succinylcholine Chloride
NDC 0143-9338

Generic Name
Succinylcholine Chloride
Dosage Form
Injection, Solution
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9501

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Haloperidol
NDC 0143-9502

Generic Name
Haloperidol Lactate
Dosage Form
Injection
Route
Intramuscular
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine
NDC 0143-9575

Generic Name
Lidocaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine
NDC 0143-9576

Generic Name
Lidocaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine
NDC 0143-9577

Generic Name
Lidocaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine
NDC 0143-9578

Generic Name
Lidocaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lidocaine
NDC 0143-9579

Generic Name
Lidocaine Hydrochloride
Dosage Form
Injection, Solution
Route
Infiltration; Perineural
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9622

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Labetalol Hydrochloride
NDC 0143-9623

Generic Name
Labetalol Hydrochloride
Dosage Form
Injection
Route
Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Flumazenil
NDC 0143-9683

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

Flumazenil
NDC 0143-9684

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

Flumazenil
NDC 0143-9783

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

Flumazenil
NDC 0143-9784

Generic Name
Flumazenil
Dosage Form
Injection, Solution
Route
Intravenous
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

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Hemorrhoidal
NDC 0113-0188

Generic Name
Mineral Oil, Petrolatum, Phenylephrine Hcl
Dosage Form
Ointment
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Hemorrhoidal
NDC 0113-0279

Generic Name
Cocoa Butter, Phenylephrine Hcl
Dosage Form
Suppository
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Cough Dm
NDC 0113-0384

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

Good Sense Anti Itch
NDC 0113-0541

Generic Name
Hydrocortisone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Itch Relief
NDC 0113-0622

Generic Name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Cough Dm
NDC 0113-0958

Generic Name
Dextromethorphan Polistirex
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Merck Sharp & Dohme LLC

NDC Product
Human Prescription Drug

Noxafil
NDC 0085-2224

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

Merz Pharmaceuticals, LLC

NDC Product
Human Prescription Drug

Cuvposa
NDC 0259-0501

Generic Name
Glycopyrrolate
Dosage Form
Liquid
Route
Oral
Marketing
NDA
Active Listing

Mission Pharmacal Company

NDC Product
Human Otc Drug

Potassium Iodide
NDC 0178-0314

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

Theragesic
NDC 0178-0320

Generic Name
Methyl Salicylate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0485

Generic Name
Sulfacetamide Sodium
Dosage Form
Shampoo
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace
NDC 0178-0499

Generic Name
Sulfacetamide Sodium
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Ovace Plus
NDC 0178-0630

Generic Name
Sodium Sulfacetamide
Dosage Form
Liquid
Route
Topical
Marketing
UNAPPROVED DRUG OTHER
Active Listing

Novartis Pharmaceuticals Corporation

NDC Product
Human Prescription Drug

Trileptal
NDC 0078-0357

Generic Name
Oxcarbazepine
Dosage Form
Suspension
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

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 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

Prednisolone Sodium Phosphate
NDC 0121-0759

Generic Name
Prednisolone Sodium Phosphate
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

Prednisolone Sodium Phosphate
NDC 0121-0773

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

Prednisolone Sodium Phosphate
NDC 0121-0777

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

Levetiracetam
NDC 0121-0799

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

Sulfamethoxazole And Trimethoprim
NDC 0121-0853

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

Sulfatrim
NDC 0121-0854

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

Nystatin
NDC 0121-0868

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

Cetirizine Hydrochloride
NDC 0121-0874

Generic Name
Cetirizine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
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

Docusate Sodium
NDC 0121-0935

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

Milk Of Magnesia Concentrate
NDC 0121-0940

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

Lidocaine Hydrochloride
NDC 0121-0950

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
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

Lidocaine Hydrochloride
NDC 0121-0972

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Topical
Marketing
ANDA
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 Prescription Drug

Lithium
NDC 0121-1027

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

Nystatin
NDC 0121-1045

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

Promethazine Dm
NDC 0121-1070

Generic Name
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Brivaracetam
NDC 0121-1074

Generic Name
Brivaracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
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 Prescription Drug

Levetiracetam
NDC 0121-1598

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

Docusate Sodium
NDC 0121-1870

Generic Name
Docusate Sodium
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-2397

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

Lithium
NDC 0121-4027

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

Valproic Acid
NDC 0121-4675

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

Calcium Carbonate
NDC 0121-4766

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

Levetiracetam
NDC 0121-4799

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

Lidocaine Hydrochloride
NDC 0121-4950

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

Senna
NDC 0121-4967

Generic Name
Sennosides
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Par Health USA, LLC

NDC Product
Human Prescription Drug

Diazoxide
NDC 0254-1010

Generic Name
Diazoxide
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Parke-Davis Div of Pfizer Inc

NDC Product
Human Prescription Drug

Lopid
NDC 0071-0737

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

Pharmaceutical Associates, Inc.

NDC Product
Human Prescription Drug

Nystatin
NDC 0121-0810

Generic Name
Nystatin
Dosage Form
Suspension
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

Nystatin
NDC 0121-4810

Generic Name
Nystatin
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Pharmacia & Upjohn Company LLC

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

Cleocin T
NDC 0009-3329

Generic Name
Clindamycin Phosphate
Dosage Form
Lotion
Route
Topical
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Depo-subq Provera
NDC 0009-4709

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

Nicotrol
NDC 0009-5401

Generic Name
Nicotine
Dosage Form
Spray, Metered
Route
Nasal
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
NDC Product
Human Prescription Drug

Aromasin
NDC 0009-7663

Generic Name
Exemestane
Dosage Form
Tablet
Route
Oral
Marketing
NDA
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

Nortriptyline Hydrochloride
NDC 0093-0810

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

Nortriptyline Hydrochloride
NDC 0093-0811

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

Nortriptyline Hydrochloride
NDC 0093-0812

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

Nortriptyline Hydrochloride
NDC 0093-0813

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

Amoxicillin
NDC 0093-2267

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

Amoxicillin
NDC 0093-2268

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

Amoxicillin
NDC 0093-3109

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

Imiquimod
NDC 0093-3133

Generic Name
Imiquimod
Dosage Form
Cream
Route
Topical
Marketing
NDA AUTHORIZED GENERIC
Active Listing
NDC Product
Human Prescription Drug

Estradiol
NDC 0093-3541

Generic Name
Estradiol
Dosage Form
Cream
Route
Vaginal
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylergonovine Maleate
NDC 0093-3655

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

Amoxicillin
NDC 0093-4155

Generic Name
Amoxicillin
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Trividia Manufacturing Solutions, Inc

NDC Product
Human Otc Drug

Selan Plus Zinc Oxide
NDC 0159-2200

Generic Name
Selan Plus Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Selan Antifungal
NDC 0159-2500

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

UCB, Inc.

NDC Product
Human Prescription Drug

Vimpat
NDC 0131-5410

Generic Name
Lacosamide
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

Viatris Specialty LLC

NDC Product
Human Prescription Drug

Proctofoam Hc
NDC 0037-6822

Generic Name
Pramoxine Hydrochloride Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Proctofoam Ns
NDC 0037-6823

Generic Name
Pramoxine Hydrochloride
Dosage Form
Aerosol, Foam
Route
Rectal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Epifoam
NDC 0037-6824

Generic Name
Pramoxine Hydrochloride And Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cortifoam
NDC 0037-6830

Generic Name
Hydrocortisone Acetate
Dosage Form
Aerosol, Foam
Route
Topical
Marketing
NDA
Active Listing

West-Ward Pharmaceuticals Corp

NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9890

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Ondansetron
NDC 0143-9891

Generic Name
Ondansetron
Dosage Form
Injection
Route
Intramuscular; Intravenous
Marketing
ANDA
Active Listing

Xttrium Laboratories Inc.

NDC Product
Human Prescription Drug

Valproic Acid
NDC 0116-4021

Generic Name
Valproic Acid
Dosage Form
Solution
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

Xttrium Laboratories, Inc.

NDC Product
Human Prescription Drug

Promethazine Hydrochloride
NDC 0116-4023

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

Lidocaine Hydrochloride
NDC 0116-4025

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

Nystatin Oral Suspension
NDC 0116-4026

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

Lidocaine Hydrochloride
NDC 0116-4027

Generic Name
Lidocaine Hydrochloride
Dosage Form
Solution
Route
Oral; Topical
Marketing
ANDA
Active Listing

External Clinical & Regulatory Resources

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