FDA.reportPublic FDA data

Carisoprodol

Product NDC
50090-3232
11-digit product format
500903232
Labeler code
50090
Product ID
50090-3232_c47ee52f-3c55-4045-bf0a-de5c7ad63237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205085
Marketing category
ANDA
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3232-02023-01-30C16284748780-1f386c649-a9a2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Carisoprodol tablets USP safely and effectively. See full prescribing information for Carisoprodol tablets USP.CARISOPRODOL tablets USP for oral use, CIVInitial U.S. Approval：1959
50090-3232-52023-01-30C16284748780-1f386c649-a9a2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Carisoprodol tablets USP safely and effectively. See full prescribing information for Carisoprodol tablets USP.CARISOPRODOL tablets USP for oral use, CIVInitial U.S. Approval：1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3232-0Carisoprodol28 in 1 BOTTLETABLET285
50090-3232-5Carisoprodol90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3232-0EA - Each50090-32324e3f8165-aa82-4bd3-bfec-62dd035c6f5712019-05-02
50090-3232-5EA - Each50090-323268abab1f-14af-42b3-b916-3af9c749225f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3232CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20190702_d6b06f62-d170-42d7-a736-2c2e54279c39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNd6b06f62-d170-42d7-a736-2c2e54279c395
197446carisoprodol 350 MG Oral TabletSCDd6b06f62-d170-42d7-a736-2c2e54279c395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3232-05009032320028 in 1 BOTTLEHistorical
50090-3232-55009032320590 TABLET in 1 BOTTLE (50090-3232-5) 90 tablet2018-05-030000-00-00NoNoCurrent