FDA.reportPublic FDA data

Carisoprodol

Product NDC
12634-437
11-digit product format
126340437
Labeler code
12634
Product ID
12634-437_29dc4824-73b8-600e-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA089346
Marketing category
ANDA
Marketing start
1991-10-17
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
2017-12-31
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
12634-437-002020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-012020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-592020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-712020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-742020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-792020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-802020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-852020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-912020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-952020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959
12634-437-962020-01-31C16284748780-19d75b9d0-8098-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-437-00Carisoprodol10 in 1 BOTTLE, PLASTICTABLET1011
12634-437-01Carisoprodol100 in 1 BOTTLE, PLASTICTABLET10011
12634-437-59Carisoprodol30 in 1 BLISTER PACKTABLET3011
12634-437-71Carisoprodol30 in 1 BOTTLETABLET3011
12634-437-74Carisoprodol24 in 1 BOTTLE, PLASTICTABLET2411
12634-437-79Carisoprodol25 in 1 BOTTLETABLET2511
12634-437-80Carisoprodol20 in 1 BOTTLE, PLASTICTABLET2011
12634-437-85Carisoprodol15 in 1 BOTTLETABLET1511
12634-437-91Carisoprodol1 in 1 BLISTER PACKTABLET111
12634-437-95Carisoprodol5 in 1 BOTTLE, PLASTICTABLET511
12634-437-96Carisoprodol6 in 1 BOTTLE, PLASTICTABLET611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-437-71EA - Each12634-437d245cd68-e598-448e-ace1-12e53a48f01112015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [APOTHECA, INC.]4
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [APOTHECA, INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARISOPRODOL TABLET [APOTHECA, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [APOTHECA, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARISOPRODOL TABLET [APOTHECA, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARISOPRODOL TABLET [APOTHECA, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARISOPRODOL TABLET [APOTHECA, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARISOPRODOL TABLET [APOTHECA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-437CARISOPRODOL TABLET [APOTHECA INC.]11Legacy NDC, 11 package rows20160121_7d7d44b4-d405-4c48-9e79-cc128dd7aaeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN7d7d44b4-d405-4c48-9e79-cc128dd7aaeb11
197446carisoprodol 350 MG Oral TabletSCD7d7d44b4-d405-4c48-9e79-cc128dd7aaeb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-437-001263404370010 in 1 BOTTLE, PLASTICHistorical
12634-437-0112634043701100 in 1 BOTTLE, PLASTICHistorical
12634-437-591263404375930 in 1 BLISTER PACKHistorical
12634-437-711263404377130 in 1 BOTTLEHistorical
12634-437-741263404377424 in 1 BOTTLE, PLASTICHistorical
12634-437-791263404377925 in 1 BOTTLEHistorical
12634-437-801263404378020 in 1 BOTTLE, PLASTICHistorical
12634-437-851263404378515 in 1 BOTTLEHistorical
12634-437-91126340437911 in 1 BLISTER PACKHistorical
12634-437-95126340437955 in 1 BOTTLE, PLASTICHistorical
12634-437-96126340437966 in 1 BOTTLE, PLASTICHistorical