FDA.reportPublic FDA data

CARISOPRODOL

Product NDC
71610-097
11-digit product format
716100097
Labeler code
71610
Product ID
71610-097_dc1fd1fb-6b4e-4c53-9c2f-7b7d8bee2f74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-07-31
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
71610-097-602023-01-30C16284748780-1f386c649-ecb8-0266-e053-dadaa90a7c1aThese 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
71610-097-702023-01-30C16284748780-1f386c649-ecb8-0266-e053-dadaa90a7c1aThese 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
71610-097-60CARISOPRODOL90 in 1 BOTTLETABLET902
71610-097-70CARISOPRODOL120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-097-60EA - Each71610-097806bad3b-eebf-4329-aa10-97ef7e162fa112018-12-13
71610-097-70EA - Each71610-097dda58c2c-5965-4cb9-b87f-10a45298e9db12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-097CARISOPRODOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20191227_89359f53-fd7e-4e31-a3fc-96f75c5f3997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN89359f53-fd7e-4e31-a3fc-96f75c5f39972
197446carisoprodol 350 MG Oral TabletSCD89359f53-fd7e-4e31-a3fc-96f75c5f39972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-097-607161000976090 TABLET in 1 BOTTLE (71610-097-60) 90 tablet2018-07-160000-00-00NoNoCurrent
71610-097-7071610009770120 TABLET in 1 BOTTLE (71610-097-70) 120 tablet2018-07-160000-00-00NoNoCurrent