Carisoprodol

Product NDC
53217-152
11-digit product format
532170152
Labeler code
53217
Product ID
53217-152_8cc17b6d-c863-4b8e-ab32-c6c2b4c35d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA087499
Marketing category
ANDA
Marketing start
1987-11-01
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
2019-12-31
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
53217-152-022020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-082020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-162020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-302020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-452020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-602020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959
53217-152-902020-01-31C16284748780-19d75b9d1-04f8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL Tablets, USP for oral use, CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-152-02Carisoprodol120 in 1 BOTTLETABLET1201
53217-152-08Carisoprodol08 in 1 BOTTLETABLET081
53217-152-16Carisoprodol16 in 1 BOTTLETABLET161
53217-152-30Carisoprodol30 in 1 BOTTLETABLET301
53217-152-45Carisoprodol45 in 1 BOTTLETABLET451
53217-152-60Carisoprodol60 in 1 BOTTLETABLET601
53217-152-90Carisoprodol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-152-02EA - Each53217-152cc97f738-a0c3-402a-af03-8055fa1e74a712017-03-06
53217-152-08EA - Each53217-1527d6cd1d2-8c1d-45c9-8efa-742311545e9212017-03-06
53217-152-16EA - Each53217-152753a9f82-0e7f-4d69-95c9-a1bd4f0098e212017-03-06
53217-152-30EA - Each53217-152cb3d8f78-a08e-40e9-8ff6-301a511b8d0b12017-03-06
53217-152-45EA - Each53217-1526d30bb4a-f7c7-409d-afdc-b18618ea976412017-03-06
53217-152-60EA - Each53217-152aabfe722-dfac-4478-aca4-26a58cabd71c12017-03-06
53217-152-90EA - Each53217-1523d427eaa-aeac-4eda-90a0-9c839038837712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-152CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 package rows20170302_f01e2d9f-3f1f-4220-8b79-077eeb9ac389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNf01e2d9f-3f1f-4220-8b79-077eeb9ac3891
197446carisoprodol 350 MG Oral TabletSCDf01e2d9f-3f1f-4220-8b79-077eeb9ac3891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-152-0253217015202120 in 1 BOTTLEHistorical
53217-152-085321701520808 in 1 BOTTLEHistorical
53217-152-165321701521616 in 1 BOTTLEHistorical
53217-152-305321701523030 in 1 BOTTLEHistorical
53217-152-455321701524545 in 1 BOTTLEHistorical
53217-152-605321701526060 in 1 BOTTLEHistorical
53217-152-905321701529090 in 1 BOTTLEHistorical