Pregabalin

Basic Information

Product Name

Pregabalin

FDA Product Code

62135-444

Regulatory Information

NDC Product Code

62135-444

Application Number

ANDA212865

Marketing Category

C73584

Effective Date

February 22, 2023

Territorial Authority

USA

FDA Title

Pregabalin Capsules These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pregabalin Capsules, for oral use, CV Initial U.S. Approval: 2004

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

PREGABALIN

Quantity: 50 mg in 1 1

Code: 55JG375S6M

Class Code: ACTIB

Active Moieties

Code: 55JG375S6M

Pregabalin

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

SHELLAC

TALC

GELATIN, UNSPECIFIED

TITANIUM DIOXIDE

PROPYLENE GLYCOL

ALCOHOL

POTASSIUM HYDROXIDE

FERROSOFERRIC OXIDE

AMMONIA

Active Moieties

PREGABALIN