Gabapentin

Product NDC
67046-226
11-digit product format
670460226
Labeler code
67046
Product ID
67046-226_7d759d91-31d3-7f77-e053-2991aa0ac364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090858
Marketing category
ANDA
Marketing start
2017-09-20
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-226IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-07IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-14IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-15IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-20IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-21IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-28IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-30IInactivated by FDA2026-08-03
excluded packagepackage67046-22667046-226-60IInactivated by FDA2026-08-03

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 · 162 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 packagepackage67046-226-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-226-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-226-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-226-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-226-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-226-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-226-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-226-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-226-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-226-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-226-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-226-15302b2466d912…e7b80fea0513…

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
A090858-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2010-12-17
A090858-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2010-12-17
A090858-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2010-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090858-001AB
A090858-002AB
A090858-003AB

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 UTC2026-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-178072bd15b7f6…

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 UTC2026-02A090858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090858-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090858-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090858-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67046-226-07These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-14These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-15These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-20These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-21These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-28These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993
67046-226-60These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use 226 232 225 Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-226-07Gabapentin7 in 1 BLISTER PACKCAPSULE72
67046-226-14Gabapentin14 in 1 BLISTER PACKCAPSULE142
67046-226-15Gabapentin15 in 1 BLISTER PACKCAPSULE152
67046-226-20Gabapentin20 in 1 BLISTER PACKCAPSULE202
67046-226-21Gabapentin21 in 1 BLISTER PACKCAPSULE212
67046-226-28Gabapentin28 in 1 BLISTER PACKCAPSULE282
67046-226-30Gabapentin30 in 1 BLISTER PACKCAPSULE302
67046-226-60Gabapentin60 in 1 BLISTER PACKCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-226GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181221_59a01ec3-97d4-c099-e053-2a91aa0af754.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAscend Laboratories, LLC722de2a9-38b3-4518-b262-ba0d1346d0ba2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepacka1006139-7dfc-4d87-a5a9-aeb380c32d242026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.896c7782-1137-454b-aaa6-28f42c7413ef2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINBryant Ranch Prepack6a0a75ac-e121-477b-a9d1-d11f588afc9d2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.7652adc6-1aad-4422-b85c-0c6b11c23b732026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.d06380d0-c894-427e-b13e-5a8f9eb86a342026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.78445dbf-c7cd-419f-a7be-72821e4966282026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals36f74fdf-0dae-47a0-a7ea-e64ac91cd88f2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINHAWAII REPACK, INC.14d61caa-17ce-4fa2-90fb-1470f3864be82026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC552912b2-be59-0333-e063-6394a90a85c02026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINNorthwind Health Company, LLC55292235-bf8f-46d0-e063-6294a90a91a52026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.3e633cd0-5ee8-4a05-bcfc-0a80209bf27f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINUnit Dose Solutions, Inc.54ecc64b-f019-9fcb-e063-6294a90a00af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.ddb3a54f-5224-4024-8804-b2a2f01d885e2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINCardinal Health 107, LLC41844c21-9e2a-4332-a8ff-9b71ae9032b02026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINCardinal Health 107, LLCd4f21e97-5e55-44c9-9b31-5f79ac2eb5122026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINREMEDYREPACK INC.fce0c123-29d7-42bf-8c8d-8be1772e2d992026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310430gabapentin 100 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-226-07670460226077 CAPSULE in 1 BLISTER PACK (67046-226-07) 7 capsule2017-09-200000-00-00NoNoCurrent
67046-226-146704602261414 CAPSULE in 1 BLISTER PACK (67046-226-14) 14 capsule2017-09-200000-00-00NoNoCurrent
67046-226-156704602261515 CAPSULE in 1 BLISTER PACK (67046-226-15) 15 capsule2017-09-200000-00-00NoNoCurrent
67046-226-206704602262020 CAPSULE in 1 BLISTER PACK (67046-226-20) 20 capsule2017-09-200000-00-00NoNoCurrent
67046-226-216704602262121 CAPSULE in 1 BLISTER PACK (67046-226-21) 21 capsule2017-09-200000-00-00NoNoCurrent
67046-226-286704602262828 CAPSULE in 1 BLISTER PACK (67046-226-28) 28 capsule2017-09-200000-00-00NoNoCurrent
67046-226-306704602263030 CAPSULE in 1 BLISTER PACK (67046-226-30) 30 capsule2017-09-200000-00-00NoNoCurrent
67046-226-606704602266060 CAPSULE in 1 BLISTER PACK (67046-226-60) 60 capsule2017-09-200000-00-00NoNoCurrent