FDA.reportPublic FDA data

Carisoprodol

Product NDC
50090-4746
11-digit product format
500904746
Labeler code
50090
Product ID
50090-4746_6678078c-f0f4-43f4-8dfd-2330372e346a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205085
Marketing category
ANDA
Marketing start
2017-05-01
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
50090-4746-02023-01-30C16284748780-1f386c649-b628-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, C-IV Initial U.S. Approval：1959
50090-4746-32023-01-30C16284748780-1f386c649-b628-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, C-IV Initial U.S. Approval：1959
50090-4746-82023-01-30C16284748780-1f386c649-b628-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, C-IV Initial U.S. Approval：1959
50090-4746-92023-01-30C16284748780-1f386c649-b628-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, C-IV Initial U.S. Approval：1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4746-0Carisoprodol30 in 1 BOTTLETABLET301
50090-4746-3Carisoprodol20 in 1 BOTTLETABLET201
50090-4746-8Carisoprodol60 in 1 BOTTLETABLET601
50090-4746-9Carisoprodol120 in 1 BOTTLETABLET1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4746CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 4 package rows20191201_859d256c-86ad-4504-bc56-3f295d683e59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN859d256c-86ad-4504-bc56-3f295d683e591
197446carisoprodol 350 MG Oral TabletSCD859d256c-86ad-4504-bc56-3f295d683e591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4746-05009047460030 TABLET in 1 BOTTLE (50090-4746-0) 30 tablet2019-11-210000-00-00NoNoCurrent
50090-4746-35009047460320 TABLET in 1 BOTTLE (50090-4746-3) 20 tablet2019-11-210000-00-00NoNoCurrent
50090-4746-85009047460860 TABLET in 1 BOTTLE (50090-4746-8) 60 tablet2019-11-210000-00-00NoNoCurrent
50090-4746-950090474609120 TABLET in 1 BOTTLE (50090-4746-9) 120 tablet2019-11-210000-00-00NoNoCurrent