Gabapentin

Product NDC
10544-447
11-digit product format
105440447
Labeler code
10544
Product ID
10544-447_a58e76e8-0645-4c40-a738-5015e88bd68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2014-04-04
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-447IInactivated by FDA2026-08-03
excluded packagepackage10544-44710544-447-02IInactivated by FDA2026-08-03
excluded packagepackage10544-44710544-447-30IInactivated by FDA2026-08-03
excluded packagepackage10544-44710544-447-60IInactivated by FDA2026-08-03
excluded packagepackage10544-44710544-447-84IInactivated by FDA2026-08-03
excluded packagepackage10544-44710544-447-90IInactivated 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.

Product history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-0687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-0687673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-065aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-065aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-068869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-068869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-06c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075360-002GABAPENTIN300MGCAPSULE / ORALAB2005-04-06c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075360-003GABAPENTIN400MGCAPSULE / ORALAB2005-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075360-001GABAPENTIN100MGCAPSULE / ORALAB2005-04-063f01610625f2…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075360-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075360-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075360-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075360-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075360-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075360-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075360-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075360-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075360-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075360-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075360-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075360-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075360-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075360-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075360-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075360-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075360-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075360-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075360-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075360-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075360-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075360-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075360-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075360-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075360-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075360-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075360-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075360-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075360-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075360-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075360-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075360-001AB13f01610625f2…

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-447-02Gabapentin120 in 1 BOTTLECAPSULE1202
10544-447-30Gabapentin30 in 1 BOTTLECAPSULE302
10544-447-60Gabapentin60 in 1 BOTTLECAPSULE602
10544-447-84Gabapentin84 in 1 BOTTLECAPSULE842
10544-447-90Gabapentin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-447-02EA - Each10544-4478c2ece05-680e-44e1-a93a-d5001630a80c12014-05-02
10544-447-30EA - Each10544-447b32d134a-ee56-4e31-8fd8-898b6394ca3312015-10-02
10544-447-60EA - Each10544-447b8329040-d29a-4607-8504-c99f04fc4e3212015-10-02
10544-447-84EA - Each10544-4473b8c0d9e-fd15-4de6-b284-29077ccfd90c12015-10-02
10544-447-90EA - Each10544-447581d790a-f480-43f0-8938-aeb13a9b4cf312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-447GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 5 package rows20140404_2550a291-51f6-473f-89cd-193bbe97662a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN2550a291-51f6-473f-89cd-193bbe97662a2
310432gabapentin 400 MG Oral CapsulePSN2550a291-51f6-473f-89cd-193bbe97662a2
310431gabapentin 300 MG Oral CapsuleSCD2550a291-51f6-473f-89cd-193bbe97662a2
310432gabapentin 400 MG Oral CapsuleSCD2550a291-51f6-473f-89cd-193bbe97662a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-447-0210544044702120 in 1 BOTTLEHistorical
10544-447-301054404473030 in 1 BOTTLEHistorical
10544-447-601054404476060 in 1 BOTTLEHistorical
10544-447-841054404478484 in 1 BOTTLEHistorical
10544-447-901054404479090 in 1 BOTTLEHistorical