Carisoprodol

Product NDC
53217-158
11-digit product format
532170158
Labeler code
53217
Product ID
53217-158_da32a585-096f-4756-88d2-a998dee90ec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA205085
Marketing category
ANDA
Marketing start
2015-06-01
Marketing end
0000-00-00
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
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
53217-158-022020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-082020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-162020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-302020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-602020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-902020-01-31C16284748780-19d75b9cf-d391-f424-e053-dadaa90a57ceThese 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
53217-158-02Carisoprodol120 in 1 BOTTLETABLET1201
53217-158-08Carisoprodol8 in 1 BOTTLETABLET81
53217-158-16Carisoprodol16 in 1 BOTTLETABLET161
53217-158-30Carisoprodol30 in 1 BOTTLETABLET301
53217-158-60Carisoprodol60 in 1 BOTTLETABLET601
53217-158-90Carisoprodol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-158-02EA - Each53217-158c66fb024-dca6-49c6-be9f-0b104889429d12017-05-03
53217-158-08EA - Each53217-1587afe7570-b21b-4826-9901-aea0b6f3a27a12017-05-03
53217-158-16EA - Each53217-158efbb7602-2d6f-41d5-94ae-8772625b091412017-05-03
53217-158-30EA - Each53217-158b147048a-598f-478f-b78a-2bf94f14ef9c12017-05-03
53217-158-60EA - Each53217-1586bf90a3f-2ee5-4357-8339-cb897deb430c12017-05-03
53217-158-90EA - Each53217-158ac3d81e7-4d1e-4619-a128-14643e0e8ac712017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-158CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20170408_893087c5-0dbe-4ee9-942f-1236b1c5ea06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN893087c5-0dbe-4ee9-942f-1236b1c5ea061
197446carisoprodol 350 MG Oral TabletSCD893087c5-0dbe-4ee9-942f-1236b1c5ea061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-158-0253217015802120 in 1 BOTTLEHistorical
53217-158-08532170158088 in 1 BOTTLEHistorical
53217-158-165321701581616 in 1 BOTTLEHistorical
53217-158-305321701583030 in 1 BOTTLEHistorical
53217-158-605321701586060 in 1 BOTTLEHistorical
53217-158-905321701589090 in 1 BOTTLEHistorical