FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0150
11-digit product format
804250150
Labeler code
80425
Product ID
80425-0150_2a99bd40-3c4e-3207-e063-6294a90a4faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 80425-0150
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

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c859e666-d510-426b-e053-2995a90a9a3cAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0150-2Gabapentin60 in 1 BOTTLECAPSULE608
80425-0150-3Gabapentin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0150-2EA - Each80425-015017c53876-8f99-4025-bc91-cd7cf6fd20bb12023-06-06
80425-0150-3EA - Each80425-0150af5735fc-2e45-4ba0-97bb-5a5ddb83c99612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0150GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 2 package rows20250101_c859e666-d510-426b-e053-2995a90a9a3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNc859e666-d510-426b-e053-2995a90a9a3c8
310430gabapentin 100 MG Oral CapsuleSCDc859e666-d510-426b-e053-2995a90a9a3c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0150-28042501500260 CAPSULE in 1 BOTTLE (80425-0150-2) 60 capsule2020-09-070000-00-00NoNoCurrent
80425-0150-38042501500390 CAPSULE in 1 BOTTLE (80425-0150-3) 90 capsule2020-09-070000-00-00NoNoCurrent