Gabapentin

Product NDC
68387-404
11-digit product format
683870404
Labeler code
68387
Product ID
68387-404_5ff43590-6bcd-4b01-8922-ed2089e9ec37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-12-15
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-404-122019-10-29C16284748780-1960f7f55-d51a-8e05-e053-dbdaa90a074aGabapentin Capsules
68387-404-602019-10-29C16284748780-1960f7f55-d51a-8e05-e053-dbdaa90a074aGabapentin Capsules
68387-404-902019-10-29C16284748780-1960f7f55-d51a-8e05-e053-dbdaa90a074aGabapentin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-404-12Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1201
68387-404-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
68387-404-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-404-12EA - Each68387-404a26d65c1-87c4-4db9-b8a2-d9644b0f6c0412012-07-24
68387-404-60EA - Each68387-404a49a4ee5-8adf-4de2-a294-c8099337652312012-07-24
68387-404-90EA - Each68387-4044ac5d9ac-1689-4082-bd15-c3ec8035a8dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-404GABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 3 package rows20110223_d08562ff-7ebf-4669-a824-933bf66b6328.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310431gabapentin 300 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310432gabapentin 400 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310430gabapentin 100 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281
310431gabapentin 300 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281
310432gabapentin 400 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-404-1268387040412120 in 1 BOTTLE, PLASTICHistorical
68387-404-606838704046060 in 1 BOTTLE, PLASTICHistorical
68387-404-906838704049090 in 1 BOTTLE, PLASTICHistorical