Home NDC 71610-069-45 gabapentin
Product NDC 71610-069
Requested package NDC 71610-069-45
11-digit product format 716100069
Labeler code 71610
Product ID 71610-069_cef6341b-bae4-4e08-a609-1afef9307f2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA077525
Marketing category ANDA
Marketing start 2006-08-24
Substance GABAPENTIN
Active strength 600 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 A077525-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2006-08-24 A077525-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2006-08-24
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 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077525-001 GABAPENTIN 600MG TABLET / ORAL 2006-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077525-002 GABAPENTIN 800MG TABLET / ORAL 2006-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB1 2006-08-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB1 2006-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB 2006-08-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB 2006-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB 2006-08-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB 2006-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB 2006-08-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB 2006-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077525-001 GABAPENTIN 600MG TABLET / ORAL AB 2006-08-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077525-002 GABAPENTIN 800MG TABLET / ORAL AB 2006-08-24 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 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 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310433 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71610-069-60 2021-03-22 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 71610-069-80 2021-03-22 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 71610-069-92 2021-03-22 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 71610-069-60 2020-01-31 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 71610-069-80 2020-01-31 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 71610-069-92 2020-01-31 These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-069-45 gabapentin 45 in 1 BOTTLE TABLET, FILM COATED 45 2 71610-069-60 gabapentin 90 in 1 BOTTLE TABLET, FILM COATED 90 2 71610-069-80 gabapentin 180 in 1 BOTTLE TABLET, FILM COATED 180 2 71610-069-92 gabapentin 270 in 1 BOTTLE TABLET, FILM COATED 270 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-069 GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20210323_7790d906-af26-4e60-bc6f-e906ec03cc24.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71610-069-45 71610006945 45 TABLET, FILM COATED in 1 BOTTLE (71610-069-45) 2021-02-26 0000-00-00 No No Current