Home NDC 76282-406 GABAPENTIN
Product NDC 76282-406
11-digit product format 762820406
Labeler code 76282
Product ID 76282-406_20a38b18-352b-47a6-b640-091b42db10aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Exelan Pharmaceuticals Inc.
Application ANDA202764
Marketing category ANDA
Marketing start 2012-11-02
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 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 A202764-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2012-10-16 A202764-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2012-10-16
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 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 · 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 76282-406-01 2023-03-23 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-05 2023-03-23 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-30 2023-03-23 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-90 2023-03-23 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-01 2023-01-30 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-05 2023-01-30 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-30 2023-01-30 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP for Oral Use, Initial U.S. Approval: 1993 76282-406-90 2023-01-30 These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP. GABAPENTIN Tablets, USP 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 76282-406-01 GABAPENTIN 100 in 1 BOTTLE TABLET, FILM COATED 100 6 76282-406-05 GABAPENTIN 500 in 1 BOTTLE TABLET, FILM COATED 500 6 76282-406-30 GABAPENTIN 30 in 1 BOTTLE TABLET, FILM COATED 30 6 76282-406-90 GABAPENTIN 90 in 1 BOTTLE TABLET, FILM COATED 90 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Gabapentin ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Gabapentin ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Gabapentin ACTIVE MOIETY 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Gabapentin ACTIVE MOIETY 6CW7F3G59X GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Crospovidone INACTIVE INGREDIENT 68401960MK GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Crospovidone INACTIVE INGREDIENT 68401960MK GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Hydroxypropyl Cellulose INACTIVE INGREDIENT RFW2ET671P GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Hypromellose 2910 (3 mpa.s) INACTIVE INGREDIENT 0VUT3PMY82 GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Hypromellose 2910 (3 mpa.s) INACTIVE INGREDIENT 0VUT3PMY82 GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Mannitol INACTIVE INGREDIENT 3OWL53L36A GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Mannitol INACTIVE INGREDIENT 3OWL53L36A GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN TABLET, FILM COATED [AVPAK] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-406 GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 4 package rows 20230324_323dad14-ded9-4432-a265-c957e46cc6db.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 · 3 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 76282-406-01 76282040601 100 TABLET, FILM COATED in 1 BOTTLE (76282-406-01) 2012-11-02 0000-00-00 No No Current 76282-406-05 76282040605 500 TABLET, FILM COATED in 1 BOTTLE (76282-406-05) 2012-11-02 0000-00-00 No No Current 76282-406-30 76282040630 30 TABLET, FILM COATED in 1 BOTTLE (76282-406-30) 2012-11-02 0000-00-00 No No Current 76282-406-90 76282040690 90 TABLET, FILM COATED in 1 BOTTLE (76282-406-90) 2012-11-02 0000-00-00 No No Current