FDA.reportPublic FDA data

Gabapentin

Product NDC
45865-122
11-digit product format
458650122
Labeler code
45865
Product ID
45865-122_b2757fb9-1777-f115-e053-2995a90acddf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
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
2021-12-31
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
45865-122-302025-01-30C16284748780-12cef2736-7c7c-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
45865-122-512025-01-30C16284748780-12cef2736-7c7c-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
45865-122-602025-01-30C16284748780-12cef2736-7c7c-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
45865-122-902025-01-30C16284748780-12cef2736-7c7c-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
45865-122-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED301
45865-122-51Gabapentin120 in 1 BOTTLETABLET, FILM COATED1201
45865-122-60Gabapentin60 in 1 BOTTLETABLET, FILM COATED601
45865-122-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-122GABAPENTIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20201025_b2757fb9-1776-f115-e053-2995a90acddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNb2757fb9-1776-f115-e053-2995a90acddf1
310433gabapentin 600 MG Oral TabletSCDb2757fb9-1776-f115-e053-2995a90acddf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-122-304586501223030 TABLET, FILM COATED in 1 BOTTLE (45865-122-30) 2014-01-110000-00-00NoNoCurrent
45865-122-5145865012251120 TABLET, FILM COATED in 1 BOTTLE (45865-122-51) 2014-01-110000-00-00NoNoCurrent
45865-122-604586501226060 TABLET, FILM COATED in 1 BOTTLE (45865-122-60) 2014-01-110000-00-00NoNoCurrent
45865-122-904586501229090 TABLET, FILM COATED in 1 BOTTLE (45865-122-90) 2014-01-110000-00-00NoNoCurrent