Gabapentin

GABAPENTIN- gabapentin tablet, film coated
Zydus Lifesciences Limited

Manufactured by:

Cadila Heathcare Ltd.

India

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-705-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

R_x only

100 tablets

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

R_x only

100 tablets

GABAPENTIN gabapentin tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-705 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg

Inactive Ingredients Ingredient Name Strength COPOVIDONE K25-31 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POLOXAMER 407 POVIDONE TALC

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 17mm Flavor Imprint Code ZE72 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-705-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-705-05 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-705-10 1000 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078926 10/16/2012

GABAPENTIN gabapentin tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-706 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (GABAPENTIN) GABAPENTIN 800 mg

Inactive Ingredients Ingredient Name Strength COPOVIDONE K25-31 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE MANNITOL POLOXAMER 407 POVIDONE TALC

Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 20mm Flavor Imprint Code ZE71 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-706-01 100 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65841-706-05 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:65841-706-10 1000 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:65841-706-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-706-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078926 10/16/2012

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-705), ANALYSIS (65841-706), MANUFACTURE (65841-705), MANUFACTURE (65841-706)

Revised: 09/2023 Zydus Lifesciences Limited