FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-5322
11-digit product format
500905322
Labeler code
50090
Product ID
50090-5322_7b63b035-fdc1-4b28-8646-540778936afe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075477
Marketing category
ANDA
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5322-02023-01-30C16284748780-1f386c649-f460-0266-e053-dadaa90a7c1aThese 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
50090-5322-12023-01-30C16284748780-1f386c649-f460-0266-e053-dadaa90a7c1aThese 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
50090-5322-0Gabapentin90 in 1 BOTTLECAPSULE901
50090-5322-1Gabapentin30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5322GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20201113_92c9d6ab-bed3-4eeb-9a6d-eb3af01335d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN92c9d6ab-bed3-4eeb-9a6d-eb3af01335d01
310432gabapentin 400 MG Oral CapsuleSCD92c9d6ab-bed3-4eeb-9a6d-eb3af01335d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5322-05009053220090 CAPSULE in 1 BOTTLE (50090-5322-0) 90 capsule2020-10-290000-00-00NoNoCurrent
50090-5322-15009053220130 CAPSULE in 1 BOTTLE (50090-5322-1) 30 capsule2020-10-290000-00-00NoNoCurrent