FDA.reportPublic FDA data

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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-447-022019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-447-302019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-447-602019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-447-842019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-447-902019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg

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