FDA.reportPublic FDA data

Carisoprodol

Product NDC
50090-0280
11-digit product format
500900280
Labeler code
50090
Product ID
50090-0280_a0629db9-fc05-46d4-a75c-1cddb44a92b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040755
Marketing category
ANDA
Marketing start
2007-02-27
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
E
Listing certified through
2018-12-31
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
50090-0280-02020-01-31C16284748780-19d75b9d0-604c-f424-e053-dadaa90a57ceThese 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
50090-0280-22020-01-31C16284748780-19d75b9d0-604c-f424-e053-dadaa90a57ceThese 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
50090-0280-32020-01-31C16284748780-19d75b9d0-604c-f424-e053-dadaa90a57ceThese 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
50090-0280-82020-01-31C16284748780-19d75b9d0-604c-f424-e053-dadaa90a57ceThese 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
50090-0280-92020-01-31C16284748780-19d75b9d0-604c-f424-e053-dadaa90a57ceThese 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
50090-0280-0Carisoprodol30 in 1 BOTTLETABLET307
50090-0280-2Carisoprodol40 in 1 BOTTLETABLET407
50090-0280-3Carisoprodol20 in 1 BOTTLETABLET207
50090-0280-8Carisoprodol60 in 1 BOTTLETABLET607
50090-0280-9Carisoprodol120 in 1 BOTTLETABLET1207

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0280CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS]7Legacy NDC, 5 package rows20171005_5dab83e5-90a1-4dae-9b72-2012670b1344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN5dab83e5-90a1-4dae-9b72-2012670b13447
197446carisoprodol 350 MG Oral TabletSCD5dab83e5-90a1-4dae-9b72-2012670b13447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0280-05009002800030 in 1 BOTTLEHistorical
50090-0280-25009002800240 in 1 BOTTLEHistorical
50090-0280-35009002800320 in 1 BOTTLEHistorical
50090-0280-85009002800860 in 1 BOTTLEHistorical
50090-0280-950090028009120 in 1 BOTTLEHistorical