FDA.reportPublic FDA data

gabapentin

Product NDC
50436-3011
11-digit product format
504363011
Labeler code
50436
Product ID
50436-3011_b1dd907e-9af0-450c-8a83-8068b6ce7dc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077525
Marketing category
ANDA
Marketing start
2006-08-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50436-3011-12020-01-31C16284748780-19d75b9d0-8215-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-3011-22020-01-31C16284748780-19d75b9d0-8215-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-3011-32020-01-31C16284748780-19d75b9d0-8215-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-3011-42020-01-31C16284748780-19d75b9d0-8215-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3011-1gabapentin90 in 1 BOTTLETABLET, FILM COATED9010
50436-3011-2gabapentin60 in 1 BOTTLETABLET, FILM COATED6010
50436-3011-3gabapentin30 in 1 BOTTLETABLET, FILM COATED3010
50436-3011-4gabapentin120 in 1 BOTTLETABLET, FILM COATED12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3011-1EA - Each50436-30113ffe88a3-d291-4e86-83eb-e6b7f1c29a8212012-07-24
50436-3011-2EA - Each50436-3011d65e2f57-dc16-4708-af38-74d1b145b9df12012-07-24
50436-3011-3EA - Each50436-3011958958ce-b8aa-4c73-ab67-34acb6fe45c912012-07-24
50436-3011-4EA - Each50436-30116e028cdf-f9b6-4886-a1cb-c7004952830612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3011GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]10Legacy NDC, 4 package rows20170307_d8f08084-ef02-4819-9842-727920232972.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNd8f08084-ef02-4819-9842-72792023297210
310433gabapentin 600 MG Oral TabletSCDd8f08084-ef02-4819-9842-72792023297210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3011-15043630110190 in 1 BOTTLEHistorical
50436-3011-25043630110260 in 1 BOTTLEHistorical
50436-3011-35043630110330 in 1 BOTTLEHistorical
50436-3011-450436301104120 in 1 BOTTLEHistorical