FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-2590
11-digit product format
500902590
Labeler code
50090
Product ID
50090-2590_8ab0c923-8ec2-4bd7-8a14-c92ca1fd8e20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075360
Marketing category
ANDA
Marketing start
2005-04-06
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2590-02023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-12023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-22023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-32023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-42023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-52023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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
50090-2590-62023-01-30C16284748780-19d75b9d0-5239-f424-e053-dadaa90a57ceThese 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2590-0Gabapentin100 in 1 BOTTLECAPSULE10020
50090-2590-1Gabapentin30 in 1 BOTTLECAPSULE3020
50090-2590-2Gabapentin60 in 1 BOTTLECAPSULE6020
50090-2590-3Gabapentin120 in 1 BOTTLECAPSULE12020
50090-2590-4Gabapentin90 in 1 BOTTLECAPSULE9020
50090-2590-5Gabapentin240 in 1 BOTTLECAPSULE24020
50090-2590-6Gabapentin270 in 1 BOTTLECAPSULE27020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2590-0EA - Each50090-25906aa1c032-e192-4ade-a021-e7a6f8f1ea2d12019-04-11
50090-2590-1EA - Each50090-2590602bebb9-2c9d-4f6e-a9cb-15cc531b55d712019-04-11
50090-2590-2EA - Each50090-2590cbaff936-d10a-4e8f-8891-560e4e0d56b712019-04-11
50090-2590-3EA - Each50090-2590f172cd4c-418c-4ed8-ba38-c4aa031c1f9e12019-04-11
50090-2590-4EA - Each50090-2590ed04a789-9a8b-4f84-8444-2a9835d7667312019-04-11
50090-2590-5EA - Each50090-25905515aa42-e685-41c1-9e5c-180547cd0d1212019-04-11
50090-2590-6EA - Each50090-25902dddbe3d-85bc-4be8-97ec-69d7cd80a7a612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2590GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]20Legacy NDC, 7 package rows20210206_39ce8bbc-7df9-45f4-ab5a-b319d2b25c88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN39ce8bbc-7df9-45f4-ab5a-b319d2b25c8820
310431gabapentin 300 MG Oral CapsuleSCD39ce8bbc-7df9-45f4-ab5a-b319d2b25c8820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2590-050090259000100 CAPSULE in 1 BOTTLE (50090-2590-0) 100 capsule2018-01-180000-00-00NoNoCurrent
50090-2590-15009025900130 CAPSULE in 1 BOTTLE (50090-2590-1) 30 capsule2017-09-270000-00-00NoNoCurrent
50090-2590-25009025900260 CAPSULE in 1 BOTTLE (50090-2590-2) 60 capsule2018-02-260000-00-00NoNoCurrent
50090-2590-350090259003120 CAPSULE in 1 BOTTLE (50090-2590-3) 120 capsule2017-08-290000-00-00NoNoCurrent
50090-2590-45009025900490 CAPSULE in 1 BOTTLE (50090-2590-4) 90 capsule2017-10-130000-00-00NoNoCurrent
50090-2590-550090259005240 CAPSULE in 1 BOTTLE (50090-2590-5) 240 capsule2017-12-290000-00-00NoNoCurrent
50090-2590-650090259006270 CAPSULE in 1 BOTTLE (50090-2590-6) 270 capsule2017-05-240000-00-00NoNoCurrent