FDA.reportPublic FDA data

CARISOPRODOL

Product NDC
67046-923
11-digit product format
670460923
Labeler code
67046
Product ID
67046-923_8b9c3b63-8df9-1bd9-e053-2a95a90a2430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA040823
Marketing category
ANDA
Marketing start
2017-10-04
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
67046-923-072020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-142020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-152020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-202020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-212020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-282020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-302020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959
67046-923-602020-01-31C16284748780-19d75b9d0-74d7-f424-e053-dadaa90a57ce923 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL safely and effectively. See full prescribing information for CARISOPRODOL CARISOPRODOL Tablets for Oral Use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-923-07CARISOPRODOL7 in 1 BLISTER PACKTABLET71
67046-923-14CARISOPRODOL14 in 1 BLISTER PACKTABLET141
67046-923-15CARISOPRODOL15 in 1 BLISTER PACKTABLET151
67046-923-20CARISOPRODOL20 in 1 BLISTER PACKTABLET201
67046-923-21CARISOPRODOL21 in 1 BLISTER PACKTABLET211
67046-923-28CARISOPRODOL28 in 1 BLISTER PACKTABLET281
67046-923-30CARISOPRODOL30 in 1 BLISTER PACKTABLET301
67046-923-60CARISOPRODOL60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-923CARISOPRODOL TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171004_5ab980c0-c4bf-233b-e053-2991aa0a4fd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN5ab980c0-c4bf-233b-e053-2991aa0a4fd11
197446carisoprodol 350 MG Oral TabletSCD5ab980c0-c4bf-233b-e053-2991aa0a4fd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-923-07670460923077 in 1 BLISTER PACKHistorical
67046-923-146704609231414 in 1 BLISTER PACKHistorical
67046-923-156704609231515 in 1 BLISTER PACKHistorical
67046-923-206704609232020 in 1 BLISTER PACKHistorical
67046-923-216704609232121 in 1 BLISTER PACKHistorical
67046-923-286704609232828 in 1 BLISTER PACKHistorical
67046-923-306704609233030 in 1 BLISTER PACKHistorical
67046-923-606704609236060 in 1 BLISTER PACKHistorical