FDA.reportPublic FDA data

GABAPENTIN

Product NDC
72189-113
11-digit product format
721890113
Labeler code
72189
Product ID
72189-113_2becf606-de3d-b686-e063-6294a90afe58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090007
Marketing category
ANDA
Marketing start
2020-10-15
Substance
GABAPENTIN
Active strength
400 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
A090007-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2011-07-21
A090007-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2011-07-21
A090007-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2011-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090007-001AB
A090007-002AB
A090007-003AB

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 22:54:322026-06A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21a50c72e98297…
2026-08-01 22:54:322026-06A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090007-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090007-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090007-003AB1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.9814b76c-87c6-4746-b712-3269352a901b2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINREMEDYREPACK INC.915cee37-536c-4761-bdb9-b96c7ee0f9562026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 72189-113
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepackc33c4d83-cc13-4104-9e24-d4cd40b17b702024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepacke2d9bd8c-3bb9-4945-8e61-7d2703d9008c2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepack5769d849-4f27-4701-97ec-7e3ca07339d72024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepack78088f6a-06a3-422f-b336-4a57a24adc162024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.8f785189-bf66-36cc-e053-2a95a90a7cbc2024-06-19Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC9d1b9121-c25a-4d28-91c5-5fc72f1167f42018-07-12Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GabapentinGABAPENTINBi-Coastal Pharma International LLCe0cd96d1-b1ef-46ec-a5a3-9505b0811b8b2016-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310432Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7e45e3f-e382-32ba-e053-2a95a90a2537Available 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
72189-113-30GABAPENTIN30 in 1 BOTTLECAPSULE3015
72189-113-60GABAPENTIN60 in 1 BOTTLECAPSULE6015
72189-113-72GABAPENTIN120 in 1 BOTTLECAPSULE12015
72189-113-90GABAPENTIN90 in 1 BOTTLECAPSULE9015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-113GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN TABLET [DIRECT RX]15Current NDC, Legacy NDC, 4 package rows20250119_a7e45e3f-e382-32ba-e053-2a95a90a2537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-113-307218901133030 CAPSULE in 1 BOTTLE (72189-113-30) 30 capsule2020-10-150000-00-00NoNoCurrent
72189-113-607218901136060 CAPSULE in 1 BOTTLE (72189-113-60) 60 capsule2020-10-150000-00-00NoNoCurrent
72189-113-7272189011372120 CAPSULE in 1 BOTTLE (72189-113-72) 120 capsule2020-10-150000-00-00NoNoCurrent
72189-113-907218901139090 CAPSULE in 1 BOTTLE (72189-113-90) 90 capsule2020-10-150000-00-00NoNoCurrent