FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-3912
11-digit product format
500903912
Labeler code
50090
Product ID
50090-3912_1d526783-464a-4b6e-8d38-62f115142f48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078926
Marketing category
ANDA
Marketing start
2012-10-16
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-3912-02023-01-30C16284748780-1f386c64a-13ff-0266-e053-dadaa90a7c1aThese 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
50090-3912-12023-01-30C16284748780-1f386c64a-13ff-0266-e053-dadaa90a7c1aThese 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
50090-3912-22023-01-30C16284748780-1f386c64a-13ff-0266-e053-dadaa90a7c1aThese 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
50090-3912-0Gabapentin60 in 1 BOTTLETABLET, FILM COATED603
50090-3912-1Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
50090-3912-2Gabapentin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3912GABAPENTIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20200121_14460d38-f4cd-43bb-8b1f-1ec299e6d155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN14460d38-f4cd-43bb-8b1f-1ec299e6d1553
310434gabapentin 800 MG Oral TabletSCD14460d38-f4cd-43bb-8b1f-1ec299e6d1553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3912-05009039120060 TABLET, FILM COATED in 1 BOTTLE (50090-3912-0) 2018-12-060000-00-00NoNoCurrent
50090-3912-15009039120190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3912-1) 2014-11-280000-00-00NoNoCurrent
50090-3912-25009039120230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3912-2) 2014-11-280000-00-00NoNoCurrent