FDA.reportPublic FDA data

Carisoprodol

Product NDC
67046-911
11-digit product format
670460911
Labeler code
67046
Product ID
67046-911_59b8ea4b-4ac1-9771-e053-2a91aa0af94b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA040245
Marketing category
ANDA
Marketing start
2017-09-21
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
67046-911-072022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-142022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-152022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-202022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-212022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-282022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-302022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-602022-01-28C16284748780-1d6a99b39-4e69-a426-e053-dadaa90af4c2911 Carisoprodol 350 mg These 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
67046-911-07Carisoprodol7 in 1 BLISTER PACKTABLET71
67046-911-14Carisoprodol14 in 1 BLISTER PACKTABLET141
67046-911-15Carisoprodol15 in 1 BLISTER PACKTABLET151
67046-911-20Carisoprodol20 in 1 BLISTER PACKTABLET201
67046-911-21Carisoprodol21 in 1 BLISTER PACKTABLET211
67046-911-28Carisoprodol28 in 1 BLISTER PACKTABLET281
67046-911-30Carisoprodol30 in 1 BLISTER PACKTABLET301
67046-911-60Carisoprodol60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-911CARISOPRODOL TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170922_59b8db2c-dbc3-d6d7-e053-2991aa0a07dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN59b8db2c-dbc3-d6d7-e053-2991aa0a07dd1
197446carisoprodol 350 MG Oral TabletSCD59b8db2c-dbc3-d6d7-e053-2991aa0a07dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-911-07670460911077 TABLET in 1 BLISTER PACK (67046-911-07) 7 tablet2017-09-210000-00-00NoNoCurrent
67046-911-146704609111414 TABLET in 1 BLISTER PACK (67046-911-14) 14 tablet2017-09-210000-00-00NoNoCurrent
67046-911-156704609111515 TABLET in 1 BLISTER PACK (67046-911-15) 15 tablet2017-09-210000-00-00NoNoCurrent
67046-911-206704609112020 TABLET in 1 BLISTER PACK (67046-911-20) 20 tablet2017-09-210000-00-00NoNoCurrent
67046-911-216704609112121 TABLET in 1 BLISTER PACK (67046-911-21) 21 tablet2017-09-210000-00-00NoNoCurrent
67046-911-286704609112828 TABLET in 1 BLISTER PACK (67046-911-28) 28 tablet2017-09-210000-00-00NoNoCurrent
67046-911-306704609113030 TABLET in 1 BLISTER PACK (67046-911-30) 30 tablet2017-09-210000-00-00NoNoCurrent
67046-911-606704609116060 TABLET in 1 BLISTER PACK (67046-911-60) 60 tablet2017-09-210000-00-00NoNoCurrent