GABAPENTIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Available from:

Zydus Lifesciences Limited

INN (International Name):

GABAPENTIN

Composition:

GABAPENTIN 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gabapentin tablets, USP are indicated for: - Management of postherpetic neuralgia in adults - Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally

Product summary:

Gabapentin Tablets USP, 600 mg are white to off-white having mottled spots, oval-shaped, biconvex, film-coated tablets debossed with 'ZE72' with bisect on one side and plain with bisect on other side and are supplied as follows: NDC 65841-705-01 in bottle of 100 tablets NDC 65841-705-05 in bottle of 500 tablets NDC65841-705-10 in bottle of 1,000 tablets Gabapentin Tablets USP, 800 mg are white to off-white having mottled spots, oval-shaped, bevelled-edge, biconvex, film-coated tablets debossed with 'ZE71' with bisect on one side and plain with bisect on other side and are supplied as follows: NDC 65841-706-01 in bottle of 100 tablets NDC 65841-706-05 in bottle of 500 tablets NDC 65841-706-10 in bottle of 1,000 tablets NDC 65841-706-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage : Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
Manufactured by:
Cadila Heathcare Ltd.
India
SPL MEDGUIDE
Revised: 9/2023
Document Id: 597b8231-e3b2-4058-ad8a-2208af0b16bb
34391-3
Set id: b033c169-4943-4ad9-ace0-7e4a1f0dc100
Version: 7
Effective Time: 20230926
Zydus Lifesciences Limited

Summary of Product characteristics

GABAPENTIN- GABAPENTIN TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
GABAPENTIN TABLETS
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 only
100 tablets
NDC 65841-706-01 in bottle of 100 tablets
Gabapentin Tablets USP, 800 mg
R only
x
x
100 tablets
GABAPENTIN
gabapentin tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-705
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
GABAPENTIN
600 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
COPOVIDONE K25-31 (UNII: D9C330MD8B)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
2 pieces
SHAPE
OVAL (OVAL)
SIZE
17mm
FLAVOR
IMPRINT CODE
Z E72
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-705-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
10/16/2012
2
NDC:65841-705-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
10/16/2012
3
NDC:65841-705-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/16/2012
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
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
GABAPENTIN
800 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
COPOVIDONE K25-31 (UNII: D9C330MD8B)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UN