Home DailyMed 8f9fbc86-2027-b203-e053-2a95a90af299 GABAPENTIN 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 Direct_Rx
Effective date 2019-08-08
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 20:29:24 Label at a glance# Product GABAPENTIN
Active ingredient GABAPENTIN
Label structure 2 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 310431 gabapentin 300 MG Oral Capsule PSN 1 310431 gabapentin 300 MG Oral Capsule SCD 1
DailyMed Pharmacologic Classes# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-640-72 GABAPENTIN 120 in 1 BOTTLE CAPSULE 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-640 GABAPENTIN CAPSULE [DIRECT_RX] 1 Current NDC, Legacy NDC, 1 package rows 20190810_8f9fbc86-2027-b203-e053-2a95a90af299.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 10 matching rows.
GABAPENTIN STARCH, CORN TALC TITANIUM DIOXIDE SHELLAC LACTOSE MONOHYDRATE ANHYDROUS LACTOSE FERRIC OXIDE YELLOW PROPYLENE GLYCOL GELATIN Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 9 matching rows.
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090007-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 A090007-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 A090007-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090007-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2011-07-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090007-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2011-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090007-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2011-07-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 · 3 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
