Gabapentin

Product NDC
63629-2593
11-digit product format
636292593
Labeler code
63629
Product ID
63629-2593_7299d664-22c0-49a0-8e3a-8f25c7bdc0f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-2593DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-0DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-1DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-2DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-3DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-4DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-5DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-6DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-7DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-8DDiscontinued by firm2026-08-11
excluded packagepackage63629-259363629-2593-9DDiscontinued by firm2026-08-11

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 3 · 154 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2593-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2593-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2593-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2593-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2593-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-2593-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-2593-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-2593-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-2593-2cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090705-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2009-12-30
A090705-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2009-12-30
A090705-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2009-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090705-001AB
A090705-002AB
A090705-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090705-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-2593-02021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-12021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-22021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-32021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-42021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-52021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-62021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-72021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-82021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-92021-08-17These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-02020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-12020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-22020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-32020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-42020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-52020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-62020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-72020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-82020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
63629-2593-92020-01-31These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2593-1EA - Each63629-2593faabd13c-645e-4794-aaa8-aef5671f921812012-07-24
63629-2593-2EA - Each63629-2593ca3bb563-3107-4b5a-a453-49953d5dd4fe12012-07-24
63629-2593-3EA - Each63629-25934430fb48-6c0d-4ee5-bf07-9e7486f2494612012-07-24
63629-2593-4EA - Each63629-259344713375-f8b8-4608-af3f-5b387d2b2ed812012-07-24
63629-2593-5EA - Each63629-2593edd86ce2-36cc-430d-9080-97c67e77a9a012012-07-24
63629-2593-6EA - Each63629-25932c49e10a-b4ef-4e41-840b-80358ad8838f12012-07-24
63629-2593-7EA - Each63629-25935d550e22-b66c-4481-92ca-df2902142ea712015-02-02
63629-2593-8EA - Each63629-2593e18d2853-a779-47d5-8d5d-5962452dc8e912015-02-02
63629-2593-9EA - Each63629-2593f3cae8a6-6223-41db-9902-d0622c48b93e12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [BRYANT RANCH PREPACK]3

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack6e7f602a-2c5f-4651-a228-5fc5bf2492052024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack1fd95278-842f-4bf9-abd5-4d9aa858d36d2024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack97a1d45d-d5b3-4be7-9b3a-cb6f80f602912024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP92c4d589-533b-4fe4-833f-dd68cc1f7e662019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCa900bafb-8f49-4a01-ba7f-4fb228ec02532018-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705