FDA.reportPublic FDA data

Gabapentin

Product NDC
50436-7286
11-digit product format
504367286
Labeler code
50436
Product ID
50436-7286_5e36627a-09e8-4614-a046-9649af9ce2fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076017
Marketing category
ANDA
Marketing start
2008-08-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50436-7286-12021-01-29C16284748780-1ba0f9c33-4b2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-7286-22021-01-29C16284748780-1ba0f9c33-4b2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-7286-32021-01-29C16284748780-1ba0f9c33-4b2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50436-7286-52021-01-29C16284748780-1ba0f9c33-4b2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-7286-1Gabapentin30 in 1 BOTTLETABLET307
50436-7286-2Gabapentin60 in 1 BOTTLETABLET607
50436-7286-3Gabapentin90 in 1 BOTTLETABLET907
50436-7286-5Gabapentin120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7286-1EA - Each50436-7286a40ff486-3e26-4da3-9442-a66e6893901512012-07-24
50436-7286-2EA - Each50436-7286b34546b2-564c-46d9-86cd-42d0059c15ef12012-07-24
50436-7286-3EA - Each50436-7286152a6155-e824-46bb-b937-c5b90430267112012-07-24
50436-7286-5EA - Each50436-7286782b305c-5a79-431c-a521-9f0c47a3fe1012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [UNIT DOSE SERVICES]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAPENTIN TABLET [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGABAPENTIN TABLET [UNIT DOSE SERVICES]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BGABAPENTIN TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7286GABAPENTIN TABLET [UNIT DOSE SERVICES]7Legacy NDC, 4 package rows20170702_6c554c68-7b9c-4863-beb2-a6a0aa45c61e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN6c554c68-7b9c-4863-beb2-a6a0aa45c61e7
310434gabapentin 800 MG Oral TabletSCD6c554c68-7b9c-4863-beb2-a6a0aa45c61e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7286-15043672860130 in 1 BOTTLEHistorical
50436-7286-25043672860260 in 1 BOTTLEHistorical
50436-7286-35043672860390 in 1 BOTTLEHistorical
50436-7286-550436728605120 in 1 BOTTLEHistorical