FDA.reportPublic FDA data

Gabapentin

Product NDC
45865-498
11-digit product format
458650498
Labeler code
45865
Product ID
45865-498_9ab2a4d1-59f1-1d78-e053-2995a90a6535
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090705
Marketing category
ANDA
Marketing start
2010-05-17
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-498-302025-01-30C16284748780-12cef2736-7839-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These 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
45865-498-602025-01-30C16284748780-12cef2736-7839-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These 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
45865-498-902025-01-30C16284748780-12cef2736-7839-d83d-e063-dadaa90ab31fHIGHLIGHTS OF PRESCRIBING INFORMATION These 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
45865-498-30Gabapentin30 in 1 BOTTLECAPSULE303
45865-498-60Gabapentin60 in 1 BOTTLECAPSULE603
45865-498-90Gabapentin90 in 1 BOTTLECAPSULE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-498GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 3 package rows20191228_1e3d9001-2d0a-2c2e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN1e3d9001-2d0a-2c2e-e054-00144ff8d46c3
310432gabapentin 400 MG Oral CapsuleSCD1e3d9001-2d0a-2c2e-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-498-304586504983030 CAPSULE in 1 BOTTLE (45865-498-30) 30 capsule2015-08-260000-00-00NoNoCurrent
45865-498-604586504986060 CAPSULE in 1 BOTTLE (45865-498-60) 60 capsule2015-08-260000-00-00NoNoCurrent
45865-498-904586504989090 CAPSULE in 1 BOTTLE (45865-498-90) 90 capsule2015-08-260000-00-00NoNoCurrent