FDA.reportPublic FDA data

Gabapentin

Product NDC
50436-1263
11-digit product format
504361263
Labeler code
50436
Product ID
50436-1263_b59d3f10-38d8-4708-82ef-fe9135f2e458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 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
50436-1263-12021-01-29C16284748780-1ba0f9c33-1871-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
50436-1263-22021-01-29C16284748780-1ba0f9c33-1871-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993
50436-1263-32021-01-29C16284748780-1ba0f9c33-1871-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for Gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1263-1Gabapentin30 in 1 BOTTLECAPSULE309
50436-1263-2Gabapentin60 in 1 BOTTLECAPSULE609
50436-1263-3Gabapentin90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1263-1EA - Each50436-126333c58945-783a-4eec-bcbb-a79a0235949412012-07-24
50436-1263-2EA - Each50436-12635a5b3f27-f303-4573-bc1d-61aacf61bf0a12012-07-24
50436-1263-3EA - Each50436-12636416f64e-c1b4-47da-9d48-9ccdb212289312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [UNIT DOSE SERVICES]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1263GABAPENTIN CAPSULE [UNIT DOSE SERVICES]9Legacy NDC, 3 package rows20170702_a2109f51-f1e5-4ba5-b3b1-3e3ebee6cf1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa2109f51-f1e5-4ba5-b3b1-3e3ebee6cf1d9
310430gabapentin 100 MG Oral CapsuleSCDa2109f51-f1e5-4ba5-b3b1-3e3ebee6cf1d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1263-15043612630130 in 1 BOTTLEHistorical
50436-1263-25043612630260 in 1 BOTTLEHistorical
50436-1263-35043612630390 in 1 BOTTLEHistorical