Home NDC 72888-131-05 Gabapentin
Product NDC 72888-131
Requested package NDC 72888-131-05
11-digit product format 728880131
Labeler code 72888
Product ID 72888-131_4b9217ba-8356-aab1-e063-6294a90a2dce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA077661
Marketing category ANDA
Marketing start 2022-09-22
Substance GABAPENTIN
Active strength 600 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 A077661-004 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 A077661-005 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13
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 3 · 86 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 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6CW7F3G59X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310433 Internal RxNorm lookup 310434 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72888-131-00 Gabapentin 1000 in 1 BOTTLE TABLET 1000 3 72888-131-01 Gabapentin 100 in 1 BOTTLE TABLET 100 3 72888-131-05 Gabapentin 500 in 1 BOTTLE TABLET 500 3 72888-131-30 Gabapentin 30 in 1 BOTTLE TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-131 GABAPENTIN TABLET [ADVAGEN PHARMA LTD] 1 Current NDC, Legacy NDC, 4 package rows 20221013_401b30fc-e143-4906-aae1-e5b5c190d4a8.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72888-131-05 72888013105 500 TABLET in 1 BOTTLE (72888-131-05) 500 tablet 2022-09-22 0000-00-00 No No Current