FDA.reportPublic FDA data

Gabapentin

Product NDC
10544-436
11-digit product format
105440436
Labeler code
10544
Product ID
10544-436_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
300 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
10544-436-002019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-022019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-302019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-452019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-602019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-812019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-842019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg
10544-436-902019-11-27C16284748780-19855e2a2-358b-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP 100 mg, 300 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-436-00Gabapentin100 in 1 BOTTLECAPSULE1002
10544-436-02Gabapentin120 in 1 BOTTLECAPSULE1202
10544-436-30Gabapentin30 in 1 BOTTLECAPSULE302
10544-436-45Gabapentin45 in 1 BOTTLECAPSULE452
10544-436-60Gabapentin60 in 1 BOTTLECAPSULE602
10544-436-81Gabapentin180 in 1 BOTTLECAPSULE1802
10544-436-84Gabapentin84 in 1 BOTTLECAPSULE842
10544-436-90Gabapentin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-436-00EA - Each10544-4367d94fe9b-70ba-4d1f-bfa1-22f622b267b512015-10-02
10544-436-02EA - Each10544-436b9bad236-fee5-45d6-94ab-8429600fe49512014-07-02
10544-436-30EA - Each10544-4363e242e1d-c593-4122-bd7c-b016fec0f8c512014-05-02
10544-436-45EA - Each10544-43628dd0e79-1c3f-4ae0-aa7c-dd97589bc61512015-10-02
10544-436-60EA - Each10544-43675d303d0-4b3b-4dd3-bd8f-62e358517f1812014-05-02
10544-436-81EA - Each10544-43654591579-e2bf-4cce-a5c7-ca0fd5a1dcbb12014-07-02
10544-436-84EA - Each10544-436e3c370d2-d13c-41d7-a6c8-668d4dbe450212015-10-02
10544-436-90EA - Each10544-4365b3755c1-a4ee-4e7b-a6a2-3fe6b7e9b2c112014-05-02

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
10544-436GABAPENTIN CAPSULE [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 8 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
10544-436-0010544043600100 in 1 BOTTLEHistorical
10544-436-0210544043602120 in 1 BOTTLEHistorical
10544-436-301054404363030 in 1 BOTTLEHistorical
10544-436-451054404364545 in 1 BOTTLEHistorical
10544-436-601054404366060 in 1 BOTTLEHistorical
10544-436-8110544043681180 in 1 BOTTLEHistorical
10544-436-841054404368484 in 1 BOTTLEHistorical
10544-436-901054404369090 in 1 BOTTLEHistorical