GABAPENTIN

Product NDC
67296-1557
Requested package NDC
67296-1557-3
11-digit product format
672961557
Labeler code
67296
Product ID
67296-1557_9c9f9120-2bbc-48ce-e053-2995a90a0b76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-09-30
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-155767296-1557-3IInactivated by FDA2026-10-05

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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204989-001RELGAABIGABAPENTIN100MGCAPSULE / ORALAB2016-02-18
A204989-002RELGAABIGABAPENTIN300MGCAPSULE / ORALAB2016-02-18
A204989-003RELGAABIGABAPENTIN400MGCAPSULE / ORALAB2016-02-18
A204989-004RELGAABIGABAPENTIN200MGCAPSULE / ORALAB2026-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204989-001AB
A204989-002AB
A204989-003AB
A204989-004AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204989-001RELGAABI100MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-002RELGAABI300MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-003RELGAABI400MGCAPSULE / ORALAB2016-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A204989-004RELGAABI200MGCAPSULE / ORALAB2026-03-0684e616aacf4f…
2026-08-18 06:07:402026-07A204989-001RELGAABI100MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-002RELGAABI300MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-003RELGAABI400MGCAPSULE / ORALAB2016-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-004RELGAABI200MGCAPSULE / ORALAB2026-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003GABAPENTIN400MGCAPSULE / ORALAB2016-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001GABAPENTIN100MGCAPSULE / ORALAB2016-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002GABAPENTIN300MGCAPSULE / ORALAB2016-02-1879d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204989-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A204989-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A204989-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204989-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204989-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204989-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204989-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204989-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204989-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204989-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204989-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204989-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204989-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204989-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204989-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204989-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204989-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204989-002AB179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1557-32022-01-28C16284748780-1d6a99b39-6bfd-a426-e053-dadaa90af4c2Gabapentin 300mg #30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1557-3GABAPENTIN30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1557GABAPENTIN CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20200121_5bfdc526-5e20-ba08-e053-2991aa0a4520.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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.d35cd5ac-5ed6-2405-e053-2995a90a69462026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack1af098ad-28b5-463f-8efa-24d70a77d64c2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack9a2658d5-9b0e-4921-b4c5-4c89f1630d692026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack43cbff48-8219-41ba-b67d-3ae4544b78bb2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINTrifluent Pharma, LLC59442de1-7cf0-35f6-e063-6294a90a57d72026-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepackcb81fd89-b32b-4538-bf5c-ab02f65b34582026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack691205ba-fa65-4bc9-ba20-7d361382cff92026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack97e47698-97c9-4eb5-a108-5850c2aa28182026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack2ac0622c-440a-49a0-974f-726e6ac72a0e2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack48037fc4-1aab-4ae8-aede-7c55b494877a2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINREMEDYREPACK INC.e877a425-2b7f-4e43-a1f9-24019cbf96852026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.16542ee6-0e0e-4d3c-8b32-60ff6ef488462026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINHAWAII REPACK, INC.dd7adad2-e2f5-4b43-90a4-522bce0be5b32026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINNorthwind Health Company, LLC1b44a3ab-4d06-205f-e063-6294a90af3682026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINAsclemed USA, Inc.9a829dc3-b2d8-4d19-a579-0597217cec9b2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb7a29b99-ce23-950e-e053-2995a90a19342026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINBryant Ranch Prepack4c49d34d-bb47-406b-8f2d-b4834b2ee9d02026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINCoupler LLC5385e27c-f2fa-32d5-e063-6294a90a0a8c2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204989
application number: ANDA204989

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN5bfdc526-5e20-ba08-e053-2991aa0a45202
310431gabapentin 300 MG Oral CapsuleSCD5bfdc526-5e20-ba08-e053-2991aa0a45202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1557-36729615570330 CAPSULE in 1 BOTTLE (67296-1557-3) 30 capsule2016-09-300000-00-00NoNoCurrent