Home NDC 0228-2637-00 Gabapentin
Product NDC 0228-2637
Requested package NDC 0228-2637-00
11-digit product format 002282637
Labeler code 0228
Product ID 0228-2637_aea65b96-e213-4141-8c3f-3eb4650985f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA075694
Marketing category ANDA
Marketing start 2004-10-04
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075694-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2004-10-21 A075694-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2004-10-21
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075694-001 GABAPENTIN 600MG TABLET / ORAL 2004-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075694-002 GABAPENTIN 800MG TABLET / ORAL 2004-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075694-001 GABAPENTIN 600MG TABLET / ORAL 2004-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075694-002 GABAPENTIN 800MG TABLET / ORAL 2004-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075694-001 GABAPENTIN 600MG TABLET / ORAL 2004-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075694-002 GABAPENTIN 800MG TABLET / ORAL 2004-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB1 2004-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB1 2004-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075694-001 GABAPENTIN 600MG TABLET / ORAL AB 2004-10-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075694-002 GABAPENTIN 800MG TABLET / ORAL AB 2004-10-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 800 mg/1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 18 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2637 GABAPENTIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 35 Legacy NDC 20241027_a33dd4d8-7d6e-4d15-ae49-9c400059c794.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 0228-2637-00 00228263700 10800 TABLET, FILM COATED in 1 BAG (0228-2637-00) 06-MAY-15 Current