FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-2539
11-digit product format
500902539
Labeler code
50090
Product ID
50090-2539_6bec72cb-a4b5-47ba-a535-cc755dc6d320
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206402
Marketing category
ANDA
Marketing start
2015-11-01
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
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
50090-2539-02023-02-07C16284748780-1f386c64a-131c-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
50090-2539-12023-02-07C16284748780-1f386c64a-131c-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
50090-2539-22023-02-07C16284748780-1f386c64a-131c-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
50090-2539-02023-01-30C16284748780-1f386c64a-131c-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
50090-2539-12023-01-30C16284748780-1f386c64a-131c-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
50090-2539-22023-01-30C16284748780-1f386c64a-131c-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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2539-0EA - Each50090-25392384231b-9bba-4c4f-ab3e-35111df0385c12019-03-12
50090-2539-1EA - Each50090-2539501bb9d4-accf-498b-bb4b-ac45b468216f12019-03-12
50090-2539-2EA - Each50090-253943c501a5-3d9d-4a11-8fdd-92be774520a912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2539GABAPENTIN TABLET [A-S MEDICATION SOLUTIONS]18Legacy NDC20241004_e7dc59e7-8734-4508-a754-0825c4d4f5ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2539-05009025390090 TABLET in 1 BOTTLE (50090-2539-0) 90 tablet2016-10-240000-00-00NoNoCurrent
50090-2539-15009025390160 TABLET in 1 BOTTLE (50090-2539-1) 60 tablet2017-02-160000-00-00NoNoCurrent
50090-2539-25009025390230 TABLET in 1 BOTTLE (50090-2539-2) 30 tablet2016-10-190000-00-00NoNoCurrent