Home NDC 76420-837 GABAPENTIN
Product NDC 76420-837
11-digit product format 764200837
Labeler code 76420
Product ID 76420-837_5c2a0ef4-73bb-7a80-e063-6294a90afdc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA214957
Marketing category ANDA
Marketing start 2021-10-01
Substance GABAPENTIN
Active strength 800 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214957-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 A214957-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 70 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 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB1 2021-10-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB1 2021-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB 2021-10-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB 2021-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB 2021-10-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB 2021-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB 2021-10-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB 2021-10-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214957-001 GABAPENTIN 600MG TABLET / ORAL AB 2021-10-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214957-002 GABAPENTIN 800MG TABLET / ORAL AB 2021-10-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base GABAPENTIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 800 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76420-837-01 GABAPENTIN 100 in 1 BOTTLE TABLET 100 2 76420-837-05 GABAPENTIN 500 in 1 BOTTLE TABLET 500 2 76420-837-30 GABAPENTIN 30 in 1 BOTTLE TABLET 30 2 76420-837-60 GABAPENTIN 60 in 1 BOTTLE TABLET 60 2 76420-837-90 GABAPENTIN 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-837 GABAPENTIN TABLET [ASCLEMED USA, INC.] 2 Current NDC, 5 package rows 20250523_1f1203f4-2184-4e13-e063-6394a90a4330.zip
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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76420-837-01 76420083701 100 TABLET in 1 BOTTLE (76420-837-01) 100 tablet 2024-08-07 No No Current 76420-837-05 76420083705 500 TABLET in 1 BOTTLE (76420-837-05) 500 tablet 2024-08-07 No No Current 76420-837-12 76420083712 120 TABLET in 1 BOTTLE (76420-837-12) 120 tablet 2026-09-23 No No Current 76420-837-30 76420083730 30 TABLET in 1 BOTTLE (76420-837-30) 30 tablet 2024-08-07 No No Current 76420-837-60 76420083760 60 TABLET in 1 BOTTLE (76420-837-60) 60 tablet 2024-08-07 No No Current 76420-837-90 76420083790 90 TABLET in 1 BOTTLE (76420-837-90) 90 tablet 2024-08-07 No No Current