FDA.reportPublic FDA data

Gabapentin

Product NDC
68151-1028
11-digit product format
681511028
Labeler code
68151
Product ID
68151-1028_ef5b0308-facf-4b40-ad45-fa9b7ac2829f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075360
Marketing category
ANDA
Marketing start
2005-04-06
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-1028IInactivated by FDA2026-08-03
excluded packagepackage68151-102868151-1028-8IInactivated by FDA2026-08-03

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
A075360-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2005-04-06
A075360-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2005-04-06
A075360-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075360-001AB
A075360-002AB
A075360-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06a50c72e98297…
2026-08-01 22:54:322026-06A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06a50c72e98297…
2026-08-01 22:54:322026-06A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075360-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075360-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075360-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINGranules Pharmaceuticals Incc681c804-c6f3-d63b-e053-2995a90a6b8f2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINBryant Ranch Prepack397fd6d3-317b-4b61-a52b-3a09ca1d88a42026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINBryant Ranch Prepack13640281-26b4-402e-8f69-7c81cd6e03762026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY3aaf3d6e-c6d5-89f5-e063-6394a90a9b772025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINGranules Pharmaceuticals Inc.b20ee34a-7f2d-4d62-a161-898565f745472025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc859e666-d510-426b-e053-2995a90a9a3c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINAsclemed USA, Inc.5fb79774-c2d4-47ba-9a16-eb367d0fdcff2023-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINProficient Rx LPaa3ab216-372a-4a72-bfd1-88a1ffa31ba32022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360
GABAPENTINGABAPENTINProficient Rx LP185f264e-db32-41cd-b90d-519717b978502021-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075360
application number: ANDA075360

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
68151-1028-82020-01-31C16284748780-19d75b9d0-417d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, USP for oral use GABAPENTIN tablets, USP for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1028-8Gabapentin1 in 1 BOTTLECAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1028GABAPENTIN CAPSULE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160616_fd0d48d6-2cfb-4221-bedc-1b16121f4d05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNfd0d48d6-2cfb-4221-bedc-1b16121f4d052
310430gabapentin 100 MG Oral CapsuleSCDfd0d48d6-2cfb-4221-bedc-1b16121f4d052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1028-8681511028081 in 1 BOTTLEHistorical