FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-1597
11-digit product format
500901597
Labeler code
50090
Product ID
50090-1597_da7f4dc5-0af5-4090-9554-9c567eee97c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
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
50090-1597-02021-06-10C16284748780-19d75b9d0-f2da-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
50090-1597-12021-06-10C16284748780-19d75b9d0-f2da-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
50090-1597-22021-06-10C16284748780-19d75b9d0-f2da-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
50090-1597-02020-01-31C16284748780-19d75b9d0-f2da-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
50090-1597-12020-01-31C16284748780-19d75b9d0-f2da-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
50090-1597-22020-01-31C16284748780-19d75b9d0-f2da-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
50090-1597-0Gabapentin30 in 1 BOTTLECAPSULE3014
50090-1597-1Gabapentin100 in 1 BOTTLECAPSULE10014
50090-1597-2Gabapentin90 in 1 BOTTLECAPSULE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1597-0EA - Each50090-1597ad9cf0de-e809-418d-861b-36a0c2c3a25f12024-05-16
50090-1597-1EA - Each50090-1597683630aa-3d3b-4998-9ce0-793d4e78f9c212024-05-16
50090-1597-2EA - Each50090-159706b5a573-8e21-417d-ab86-45c5c4b79e8912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1597GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]12Legacy NDC, 3 package rows20250406_d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsulePSNd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310430gabapentin 100 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414
310432gabapentin 400 MG Oral CapsuleSCDd25daaac-a8ab-4f12-acc2-4ec8fc97a2d414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1597-05009015970030 in 1 BOTTLEHistorical
50090-1597-150090159701100 in 1 BOTTLEHistorical
50090-1597-25009015970290 in 1 BOTTLEHistorical