FDA.reportPublic FDA data

Carisoprodol

Product NDC
50436-2582
11-digit product format
504362582
Labeler code
50436
Product ID
50436-2582_84b48aca-be5f-4647-a2d1-d492e74f23c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040245
Marketing category
ANDA
Marketing start
1997-09-08
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
50436-2582-12021-01-29C16284748780-1ba0f9c33-4677-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-2582-22021-01-29C16284748780-1ba0f9c33-4677-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-2582-32021-01-29C16284748780-1ba0f9c33-4677-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959
50436-2582-42021-01-29C16284748780-1ba0f9c33-4677-a910-e053-dadaa90a0b85These 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 CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-2582-1Carisoprodol30 in 1 BOTTLETABLET309
50436-2582-2Carisoprodol60 in 1 BOTTLETABLET609
50436-2582-3Carisoprodol90 in 1 BOTTLETABLET909
50436-2582-4Carisoprodol120 in 1 BOTTLETABLET1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-2582-1EA - Each50436-2582a15c87f4-432b-40f5-b2e8-734a7c95da7012017-09-11
50436-2582-2EA - Each50436-2582b9d76687-2943-4af8-b5f8-99a91c7b6c5812017-09-11
50436-2582-3EA - Each50436-25823b338283-f2e7-49f7-9539-cf9d21e0b39012017-09-11
50436-2582-4EA - Each50436-2582faeed5d4-4180-47a4-aa8f-a0daf228347412017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2582CARISOPRODOL TABLET [UNIT DOSE SERVICES]9Legacy NDC, 4 package rows20190813_4f7d1f4b-ba8c-4480-99de-b07d70be1553.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN4f7d1f4b-ba8c-4480-99de-b07d70be15539
197446carisoprodol 350 MG Oral TabletSCD4f7d1f4b-ba8c-4480-99de-b07d70be15539

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-2582-15043625820130 in 1 BOTTLEHistorical
50436-2582-25043625820260 in 1 BOTTLEHistorical
50436-2582-35043625820390 in 1 BOTTLEHistorical
50436-2582-450436258204120 in 1 BOTTLEHistorical