Gabapentin (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-204-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

Rx only

100 tablets

ZYDUS

Gabapentin tablets
(click image for full-size original)

NDC 68382-205-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

Rx only

100 tablets

ZYDUS

Gabapentin tablets
(click image for full-size original)
GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-204
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:68382-204-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-204-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-204-10 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:68382-205
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:68382-205-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-205-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-205-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-205-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-205-30)
4 NDC:68382-205-30 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68382-205-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078926 10/16/2012
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (68382-204), ANALYSIS (68382-205), MANUFACTURE (68382-204), MANUFACTURE (68382-205)

Revised: 04/2021 Zydus Pharmaceuticals (USA) Inc.

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