FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1287
11-digit product format
713351287
Labeler code
71335
Product ID
71335-1287_d8604417-9d43-4d27-a7ce-d4120ff201f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207057
Marketing category
ANDA
Marketing start
2019-05-01
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
2023-12-31
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
71335-1287-02024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-12024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-22024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-32024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-42024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-52024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-62024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-72024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-82024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-92024-01-30C16284748780-11030e365-342a-111a-e063-dadaa90a10e2These 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
71335-1287-0Gabapentin28 in 1 BOTTLETABLET, COATED282
71335-1287-1Gabapentin30 in 1 BOTTLETABLET, COATED302
71335-1287-2Gabapentin60 in 1 BOTTLETABLET, COATED602
71335-1287-3Gabapentin180 in 1 BOTTLETABLET, COATED1802
71335-1287-4Gabapentin90 in 1 BOTTLETABLET, COATED902
71335-1287-5Gabapentin100 in 1 BOTTLETABLET, COATED1002
71335-1287-6Gabapentin120 in 1 BOTTLETABLET, COATED1202
71335-1287-7Gabapentin500 in 1 BOTTLETABLET, COATED5002
71335-1287-8Gabapentin84 in 1 BOTTLETABLET, COATED842
71335-1287-9Gabapentin112 in 1 BOTTLETABLET, COATED1122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1287-2EA - Each71335-12876a43ace6-b388-432d-a081-eedc55b9eb0712019-11-12
71335-1287-4EA - Each71335-12871e771e44-d141-4ea2-9b3b-804e4945d97912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1287GABAPENTIN TABLET, COATED [BRYANT RANCH PREPACK]2Legacy NDC, 10 package rows20220204_d8604417-9d43-4d27-a7ce-d4120ff201f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNd8604417-9d43-4d27-a7ce-d4120ff201f42
310433gabapentin 600 MG Oral TabletSCDd8604417-9d43-4d27-a7ce-d4120ff201f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1287-07133512870028 TABLET, COATED in 1 BOTTLE (71335-1287-0) 2019-05-010000-00-00NoNoCurrent
71335-1287-17133512870130 TABLET, COATED in 1 BOTTLE (71335-1287-1) 2019-05-010000-00-00NoNoCurrent
71335-1287-27133512870260 TABLET, COATED in 1 BOTTLE (71335-1287-2) 2019-05-010000-00-00NoNoCurrent
71335-1287-371335128703180 TABLET, COATED in 1 BOTTLE (71335-1287-3) 2019-05-010000-00-00NoNoCurrent
71335-1287-47133512870490 TABLET, COATED in 1 BOTTLE (71335-1287-4) 2019-05-010000-00-00NoNoCurrent
71335-1287-571335128705100 TABLET, COATED in 1 BOTTLE (71335-1287-5) 2019-05-010000-00-00NoNoCurrent
71335-1287-671335128706120 TABLET, COATED in 1 BOTTLE (71335-1287-6) 2019-05-010000-00-00NoNoCurrent
71335-1287-771335128707500 TABLET, COATED in 1 BOTTLE (71335-1287-7) 2019-05-010000-00-00NoNoCurrent
71335-1287-87133512870884 TABLET, COATED in 1 BOTTLE (71335-1287-8) 2019-05-010000-00-00NoNoCurrent
71335-1287-971335128709112 TABLET, COATED in 1 BOTTLE (71335-1287-9) 2019-05-010000-00-00NoNoCurrent