FDA.reportPublic FDA data

Gabapentin

Product NDC
45865-405
11-digit product format
458650405
Labeler code
45865
Product ID
45865-405_7203ebe3-1693-9273-e053-2995a90a04c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
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
45865-405-302025-01-30C16284748780-12cef2736-69e0-d83d-e063-dadaa90ab31fThese 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
45865-405-902025-01-30C16284748780-12cef2736-69e0-d83d-e063-dadaa90ab31fThese 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
45865-405-30Gabapentin30 in 1 BOTTLETABLET301
45865-405-90Gabapentin90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-405GABAPENTIN TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180728_7203ebe3-1692-9273-e053-2995a90a04c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN7203ebe3-1692-9273-e053-2995a90a04c51
310434gabapentin 800 MG Oral TabletSCD7203ebe3-1692-9273-e053-2995a90a04c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-405-304586504053030 TABLET in 1 BOTTLE (45865-405-30) 30 tablet2018-01-010000-00-00NoNoCurrent
45865-405-904586504059090 TABLET in 1 BOTTLE (45865-405-90) 90 tablet2018-01-010000-00-00NoNoCurrent