Gabapentin

GABAPENTIN- gabapentin tablet, film coated
Cadila Healthcare Limited

Manufactured by:

Cadila Heathcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-705-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

Rx only

100 tablets

Gabapentin tablets
(click image for full-size original)

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

Rx only

100 tablets

Gabapentin tablets
(click image for full-size original)
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 — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-705), ANALYSIS (65841-706), MANUFACTURE (65841-705), MANUFACTURE (65841-706)

Revised: 08/2020 Cadila Healthcare Limited

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