Gabapentin

Product NDC
66116-407
11-digit product format
661160407
Labeler code
66116
Product ID
66116-407_38d9d7d7-9f81-4517-acee-e34232215800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
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
66116-407-602019-11-13C16284748780-197449f38-c008-f6ea-e053-dbdaa90aa703Gabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-407-60Gabapentin60 in 1 BOTTLECAPSULE601

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-407GABAPENTIN CAPSULE [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111220_38d9d7d7-9f81-4517-acee-e34232215800.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN38d9d7d7-9f81-4517-acee-e342322158001
310431gabapentin 300 MG Oral CapsuleSCD38d9d7d7-9f81-4517-acee-e342322158001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-407-606611604076060 in 1 BOTTLEHistorical