GABAPENTIN

Product NDC
61919-101
11-digit product format
619190101
Labeler code
61919
Product ID
61919-101_7d9af18b-1edc-4f6b-a4aa-5cca7652b600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA077242
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-101-722020-01-31C16284748780-19d75b9d0-7987-f424-e053-dadaa90a57ceGABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-101-30GABAPENTIN30 in 1 BOTTLECAPSULE302
61919-101-60GABAPENTIN60 in 1 BOTTLECAPSULE602
61919-101-72GABAPENTIN120 in 1 BOTTLECAPSULE1202
61919-101-90GABAPENTIN90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-101-30EA - Each61919-1018daf6c09-f3d2-451c-9d97-3613aa1f984912014-05-02
61919-101-60EA - Each61919-1011020acc8-ab59-470d-a97e-762adc23572d12014-05-02
61919-101-72EA - Each61919-10132d37f10-37c0-40ad-8dff-a4404f53ea8e12014-05-02
61919-101-90EA - Each61919-10131cf34df-f040-44e4-9571-e9e739e0678712014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-101GABAPENTIN CAPSULE [DIRECT RX]2Legacy NDC, 4 package rows20150814_52e49778-03f1-43cb-b75d-6c1adbb96ec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310431gabapentin 300 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310432gabapentin 400 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310430gabapentin 100 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62
310431gabapentin 300 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62
310432gabapentin 400 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-101-306191901013030 in 1 BOTTLEHistorical
61919-101-606191901016060 in 1 BOTTLEHistorical
61919-101-7261919010172120 in 1 BOTTLEHistorical
61919-101-906191901019090 in 1 BOTTLEHistorical