Home NDC 71610-630 GABAPENTIN
Product NDC 71610-630
11-digit product format 716100630
Labeler code 71610
Product ID 71610-630_12e0dcb9-e210-413b-9c77-cdeccd600e82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA214957
Marketing category ANDA
Marketing start 2021-10-01
Substance GABAPENTIN
Active strength 800 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 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 800 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 310434 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-630 GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Current NDC, Legacy NDC, 8 package rows 20220512_17988b64-723c-488d-befd-3e4e4cc44bd2.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 Marketing end Sample Exclude flag Status 71610-630-30 71610063030 30 TABLET in 1 BOTTLE (71610-630-30) 30 tablet 2022-04-20 0000-00-00 No No Current 71610-630-45 71610063045 45 TABLET in 1 BOTTLE (71610-630-45) 45 tablet 2022-04-20 0000-00-00 No No Current 71610-630-53 71610063053 60 TABLET in 1 BOTTLE (71610-630-53) 60 tablet 2022-04-20 0000-00-00 No No Current 71610-630-60 71610063060 90 TABLET in 1 BOTTLE (71610-630-60) 90 tablet 2022-04-20 0000-00-00 No No Current 71610-630-70 71610063070 120 TABLET in 1 BOTTLE (71610-630-70) 120 tablet 2022-04-20 0000-00-00 No No Current 71610-630-73 71610063073 135 TABLET in 1 BOTTLE (71610-630-73) 135 tablet 2022-04-20 0000-00-00 No No Current 71610-630-80 71610063080 180 TABLET in 1 BOTTLE (71610-630-80) 180 tablet 2022-01-25 0000-00-00 No No Current 71610-630-92 71610063092 270 TABLET in 1 BOTTLE (71610-630-92) 270 tablet 2022-01-25 0000-00-00 No No Current