Gabapentin Tablets

SPL v8

SPL

SPL Set ID b033c169-4943-4ad9-ace0-7e4a1f0dc100

Route

ORAL

Published

Effective Date 2023-09-26

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Gabapentin (600 mg)

Inactive Ingredients

Copovidone K25-31 Hydroxypropyl Cellulose, Low Substituted Magnesium Stearate Mannitol Poloxamer 407 Povidone Talc

Identifiers & Packaging

Pill Appearance

Imprint: ZE71 Shape: oval Color: white Size: 17 mm Size: 20 mm Score: 2

Marketing Status

ANDA Active Since 2012-10-16

Description

Manufactured by: Cadila Heathcare Ltd. India

Medication Information

Description

Manufactured by: Cadila Heathcare Ltd. India

Section 42231-1

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

R_xonly

100 tablets

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

R_xonly

100 tablets

Structured Label Content

Section 42231-1 (42231-1)

Manufactured by:

Cadila Heathcare Ltd.

India

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-705-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

R_xonly

100 tablets

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

R_xonly

100 tablets

Advanced Ingredient Data

[{"name": "GABAPENTIN", "unii": "6CW7F3G59X", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "COPOVIDONE K25-31", "unii": "D9C330MD8B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED", "unii": "2165RE0K14", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GABAPENTIN", "unii": "6CW7F3G59X", "classCode": "ACTIB", "strengthNumerator": "800", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "COPOVIDONE K25-31", "unii": "D9C330MD8B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED", "unii": "2165RE0K14", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42231-1": "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 R x only 100 tablets NDC 65841-706-01 in bottle of 100 tablets Gabapentin Tablets USP, 800 mg R x only 100 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:58.985958 · Updated: 2026-03-14T22:18:18.443233