MedPath
FDA Product

PREGABALIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

PREGABALIN

72189-251

Regulatory Information

72189-251

ANDA208677

C73584

July 5, 2023

USA

PREGABALIN

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

Direct_Rx

079254320

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

PREGABALIN

Quantity: 300 mg in 1 1

Code: 55JG375S6M

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

PREGABALIN

Code: 55JG375S6M

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