FDA.reportPublic FDA data

Carisoprodol

Product NDC
50436-0451
11-digit product format
504360451
Labeler code
50436
Product ID
50436-0451_e72c639a-4aed-4033-880b-4db590598842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA205085
Marketing category
ANDA
Marketing start
2018-07-17
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
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
50436-0451-12021-01-29C16284748780-1ba0f9c33-3d0b-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-0451-22021-01-29C16284748780-1ba0f9c33-3d0b-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-0451-32021-01-29C16284748780-1ba0f9c33-3d0b-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-0451-42021-01-29C16284748780-1ba0f9c33-3d0b-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0451-1Carisoprodol30 in 1 BOTTLETABLET302
50436-0451-2Carisoprodol60 in 1 BOTTLETABLET602
50436-0451-3Carisoprodol90 in 1 BOTTLETABLET902
50436-0451-4Carisoprodol120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0451-1EA - Each50436-045192ff3f55-dbd1-42fb-8c4c-ead52d84161612019-10-07
50436-0451-2EA - Each50436-0451c874bc51-8e63-4e4c-83db-256a34b52de012019-10-07
50436-0451-3EA - Each50436-045155b67857-f5ce-4683-bb70-497cd53f980a12019-10-07
50436-0451-4EA - Each50436-0451c4600904-53c7-48d1-ab4b-98b4faa6747212019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0451CARISOPRODOL TABLET [UNIT DOSE SERVICES]2Legacy NDC, 4 package rows20190913_5c15e8eb-2290-47f4-8cc9-197e9e482a30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN5c15e8eb-2290-47f4-8cc9-197e9e482a302
197446carisoprodol 350 MG Oral TabletSCD5c15e8eb-2290-47f4-8cc9-197e9e482a302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0451-15043604510130 in 1 BOTTLEHistorical
50436-0451-25043604510260 in 1 BOTTLEHistorical
50436-0451-35043604510390 in 1 BOTTLEHistorical
50436-0451-450436045104120 in 1 BOTTLEHistorical