Gabapentin

Product NDC
53002-3423
Requested package NDC
53002-3423-3
11-digit product format
530023423
Labeler code
53002
Product ID
53002-3423_c106dd29-d11a-4299-ad56-695b61129c7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075350
Marketing category
ANDA
Marketing start
2014-04-03
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 packagepackage53002-342353002-3423-3IInactivated by FDA2026-08-11

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 1 · 9 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 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A075350-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2003-09-12
A075350-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2003-09-12
A075350-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2003-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075350-001AB
A075350-002AB
A075350-003AB

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 UTC2026-02A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-002GABAPENTIN300MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-003GABAPENTIN400MGCAPSULE / ORALAB2003-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075350-001GABAPENTIN100MGCAPSULE / ORALAB2003-09-128072bd15b7f6…

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 UTC2026-02A075350-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075350-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075350-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075350-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075350-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075350-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075350-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075350-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075350-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075350-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075350-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075350-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075350-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075350-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075350-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075350-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075350-001AB18072bd15b7f6…

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, Effective, Related label table
NDCEffectiveRelated label
53002-3423-02025-01-30These 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 Initial U.S. Approval: 1993
53002-3423-32025-01-30These 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 Initial U.S. Approval: 1993
53002-3423-62025-01-30These 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 Initial U.S. Approval: 1993
53002-3423-02023-06-07These 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 Initial U.S. Approval: 1993
53002-3423-32023-06-07These 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 Initial U.S. Approval: 1993
53002-3423-62023-06-07These 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 Initial U.S. Approval: 1993
53002-3423-02023-01-30These 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 Initial U.S. Approval: 1993
53002-3423-32023-01-30These 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 Initial U.S. Approval: 1993
53002-3423-62023-01-30These 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 Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3423-0Gabapentin100 in 1 BOTTLECAPSULE1003
53002-3423-3Gabapentin30 in 1 BOTTLECAPSULE303
53002-3423-6Gabapentin60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3423GABAPENTIN CAPSULE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_bb0f1cee-1ab7-4306-9023-9553f1bacb50.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINTeva Pharmaceuticals, Inc.c7f21eaa-68ee-420c-9c98-e997cc73a2972026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.b4c7388a-19d9-4e3a-83c9-4943fb855be42025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc80b8b-da39-6fb9-e053-2a95a90a2d8e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINBryant Ranch Prepack77754734-4125-42b1-97c8-458bcab2bcf12024-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINProficient Rx LPc7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAsclemed USA, Inc.e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc82022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINProficient Rx LPf651a143-3f88-49c9-b5c4-c9af55aea76a2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC37d4d465-19a5-46db-80dc-0b7334b3343a2018-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC86b30e64-fe56-42b3-a0f8-d9ef5d4b8c492016-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075350
application number: ANDA075350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNbb0f1cee-1ab7-4306-9023-9553f1bacb503
310431gabapentin 300 MG Oral CapsuleSCDbb0f1cee-1ab7-4306-9023-9553f1bacb503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3423-35300234230330 CAPSULE in 1 BOTTLE (53002-3423-3) 30 capsule2020-01-010000-00-00NoNoCurrent