FDA.reportPublic FDA data

GABAPENTIN

Product NDC
64725-0138
11-digit product format
647250138
Labeler code
64725
Product ID
64725-0138_dbba4900-cfca-4dd9-8241-b8a675ab6128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077242
Marketing category
ANDA
Marketing start
2006-08-24
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0138-12019-11-27C16284748780-19855e2a2-4224-60a7-e053-dbdaa90a05bdGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0138-1GABAPENTIN60 in 1 BOTTLECAPSULE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0138GABAPENTIN CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140902_249e184c-8996-4206-8ee3-b6faa46d3188.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN249e184c-8996-4206-8ee3-b6faa46d31882
310431gabapentin 300 MG Oral CapsuleSCD249e184c-8996-4206-8ee3-b6faa46d31882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0138-16472501380160 in 1 BOTTLEHistorical