FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-5045
11-digit product format
500905045
Labeler code
50090
Product ID
50090-5045_a42502f6-622a-4f0d-bff9-bc4e4ba63c18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
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
2022-12-31
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
50090-5045-02023-01-30C16284748780-1f386c64a-1a99-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5045-12023-01-30C16284748780-1f386c64a-1a99-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
50090-5045-22023-01-30C16284748780-1f386c64a-1a99-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5045-0Gabapentin60 in 1 BOTTLETABLET603
50090-5045-1Gabapentin90 in 1 BOTTLETABLET903
50090-5045-2Gabapentin30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5045GABAPENTIN TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20210417_f1bce199-9f88-4a94-9006-8e148dedd45f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNf1bce199-9f88-4a94-9006-8e148dedd45f3
310434gabapentin 800 MG Oral TabletSCDf1bce199-9f88-4a94-9006-8e148dedd45f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5045-05009050450060 TABLET in 1 BOTTLE (50090-5045-0) 60 tablet2020-05-130000-00-00NoNoCurrent
50090-5045-15009050450190 TABLET in 1 BOTTLE (50090-5045-1) 90 tablet2020-05-130000-00-00NoNoCurrent
50090-5045-25009050450230 TABLET in 1 BOTTLE (50090-5045-2) 30 tablet2020-05-130000-00-00NoNoCurrent