FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-3582
11-digit product format
500903582
Labeler code
50090
Product ID
50090-3582_854f89a1-5eb8-4df2-b91a-7fbd3e297bc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50090-3582-02020-01-31C16284748780-19d75b9d0-90c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3582-0Gabapentin33 in 1 BOX, UNIT-DOSECAPSULE333
50090-3582-0Gabapentin1 in 1 BLISTER PACKCAPSULE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3582-0EA - Each50090-35820cee11de-be3d-467d-a07a-9aaa77047ec212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3582GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20180921_afdf2bf9-9ada-4f53-bf5a-7961a3244121.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNafdf2bf9-9ada-4f53-bf5a-7961a32441213
310430gabapentin 100 MG Oral CapsuleSCDafdf2bf9-9ada-4f53-bf5a-7961a32441213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3582-05009035820033 in 1 BOX, UNIT-DOSEHistorical