FDA.reportPublic FDA data

Gabapentin

Product NDC
50436-7210
11-digit product format
504367210
Labeler code
50436
Product ID
50436-7210_c3bd926e-5274-42be-88e6-b4d2051d5d42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
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
50436-7210-12021-01-29C16284748780-1ba0f9c33-3702-a910-e053-dadaa90a0b85These 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
50436-7210-22021-01-29C16284748780-1ba0f9c33-3702-a910-e053-dadaa90a0b85These 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
50436-7210-32021-01-29C16284748780-1ba0f9c33-3702-a910-e053-dadaa90a0b85These 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
50436-7210-42021-01-29C16284748780-1ba0f9c33-3702-a910-e053-dadaa90a0b85These 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
50436-7210-1Gabapentin30 in 1 BOTTLETABLET304
50436-7210-2Gabapentin60 in 1 BOTTLETABLET604
50436-7210-3Gabapentin90 in 1 BOTTLETABLET904
50436-7210-4Gabapentin120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7210-1EA - Each50436-7210da409351-069a-49ad-b2be-c1db6bb2388312017-11-06
50436-7210-2EA - Each50436-72102eb9ab16-96f3-4ff7-a15a-78f24a75c7fd12017-11-06
50436-7210-3EA - Each50436-7210850b8cc6-01f2-412c-b2ce-76f2c33d0db012017-11-06
50436-7210-4EA - Each50436-7210535b9987-78c0-49aa-b87f-ac931bcaae2412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7210GABAPENTIN TABLET [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20171011_b4e95e49-2218-4150-bf23-71645114eb8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNb4e95e49-2218-4150-bf23-71645114eb8c4
310434gabapentin 800 MG Oral TabletPSNb4e95e49-2218-4150-bf23-71645114eb8c4
310433gabapentin 600 MG Oral TabletSCDb4e95e49-2218-4150-bf23-71645114eb8c4
310434gabapentin 800 MG Oral TabletSCDb4e95e49-2218-4150-bf23-71645114eb8c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7210-15043672100130 in 1 BOTTLEHistorical
50436-7210-25043672100260 in 1 BOTTLEHistorical
50436-7210-35043672100390 in 1 BOTTLEHistorical
50436-7210-450436721004120 in 1 BOTTLEHistorical