Home DailyMed 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 Gabapentin Tablets Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited | Zydus Pharmaceuticals Limited
Effective date 2025-09-15
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 3
Source full-release
Hydrated at 2026-05-31 21:43:20 Label at a glance# Product gabapentin
Active ingredient GABAPENTIN
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1806380 gabapentin 300 MG Once-Daily Oral Tablet PSN 3 2634747 gabapentin 450 MG Once-Daily Oral Tablet PSN 3 1806382 gabapentin 600 MG Once-Daily Oral Tablet PSN 3 2634751 gabapentin 750 MG Once-Daily Oral Tablet PSN 3 2634743 gabapentin 900 MG Once-Daily Oral Tablet PSN 3 1806380 Once-Daily gabapentin 300 MG Oral Tablet SCD 3 2634747 Once-Daily gabapentin 450 MG Oral Tablet SCD 3 1806382 Once-Daily gabapentin 600 MG Oral Tablet SCD 3 2634751 Once-Daily gabapentin 750 MG Oral Tablet SCD 3 2634743 Once-Daily gabapentin 900 MG Oral Tablet SCD 3 1806380 gabapentin 300 MG Once-Daily Oral Tablet SY 3 2634747 gabapentin 450 MG Once-Daily Oral Tablet SY 3 1806382 gabapentin 600 MG Once-Daily Oral Tablet SY 3 2634751 gabapentin 750 MG Once-Daily Oral Tablet SY 3 2634743 gabapentin 900 MG Once-Daily Oral Tablet SY 3
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 9 matching rows.
gabapentin CELLULOSE, MICROCRYSTALLINE COPOVIDONE K25-31 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 2 · 45 matching rows.
Name, UNII, Kind table Name UNII Kind GABAPENTIN 6CW7F3G59X ACTIB CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT COPOVIDONE K25-31 D9C330MD8B IACT HYPROMELLOSE, UNSPECIFIED 3NXW29V3WO IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POVIDONE, UNSPECIFIED FZ989GH94E IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT GABAPENTIN 6CW7F3G59X ACTIB CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT COPOVIDONE K25-31 D9C330MD8B IACT HYPROMELLOSE, UNSPECIFIED 3NXW29V3WO IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POVIDONE, UNSPECIFIED FZ989GH94E IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT GABAPENTIN 6CW7F3G59X ACTIB CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT COPOVIDONE K25-31 D9C330MD8B IACT HYPROMELLOSE, UNSPECIFIED 3NXW29V3WO IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POVIDONE, UNSPECIFIED FZ989GH94E IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT GABAPENTIN 6CW7F3G59X ACTIB CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT COPOVIDONE K25-31 D9C330MD8B IACT HYPROMELLOSE, UNSPECIFIED 3NXW29V3WO IACT MAGNESIUM STEARATE 70097M6I30 IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT POVIDONE, UNSPECIFIED FZ989GH94E IACT TALC 7SEV7J4R1U IACT TITANIUM DIOXIDE 15FIX9V2JP IACT GABAPENTIN 6CW7F3G59X ACTIB CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT COPOVIDONE K25-31 D9C330MD8B IACT HYPROMELLOSE, UNSPECIFIED 3NXW29V3WO IACT
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203934-001 GABAPENTIN GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 A203934-002 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 A203934-003 GABAPENTIN GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 A203934-004 GABAPENTIN GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 A203934-005 GABAPENTIN GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 58 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-003 GABAPENTIN 450MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-004 GABAPENTIN 750MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203934-005 GABAPENTIN 900MG TABLET / ORAL AB 2025-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203934-002 GABAPENTIN 600MG TABLET / ORAL AB2 2024-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203934-001 GABAPENTIN 300MG TABLET / ORAL AB2 2024-01-24 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.