Pregabalin

Basic Information

Product Name

Pregabalin

FDA Product Code

69539-013

Regulatory Information

NDC Product Code

69539-013

Application Number

ANDA209357

Marketing Category

C73584

Effective Date

November 16, 2022

Territorial Authority

USA

FDA Title

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

PREGABALIN

Quantity: 75 mg in 1 1

Code: 55JG375S6M

Class Code: ACTIB

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

SHELLAC

Code: MB5IUD6JUA

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

Code: 55JG375S6M

Pregabalin

Basic Information

Regulatory Information

Company Information

Active Ingredients

MANNITOL

TALC

TITANIUM DIOXIDE

GELATIN

FD&C BLUE NO. 2

SHELLAC

PROPYLENE GLYCOL

FERROSOFERRIC OXIDE

POTASSIUM HYDROXIDE

SODIUM LAURYL SULFATE

Active Moieties

PREGABALIN