FDA.reportPublic FDA data

carisoprodol

Product NDC
65862-693
11-digit product format
658620693
Labeler code
65862
Product ID
65862-693_75754a95-33cf-4bfb-bee1-7d308a227250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA040792
Marketing category
ANDA
Marketing start
2016-11-08
Substance
CARISOPRODOL
Active strength
250 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
carisoprodol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21925K482H
Rxcui197446, 730794

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-693-01carisoprodol100 in 1 BOTTLETABLET10017
65862-693-30carisoprodol30 in 1 BOTTLETABLET3017
65862-693-60carisoprodol60 in 1 BOTTLETABLET6017
65862-693-90carisoprodol90 in 1 BOTTLETABLET9017
65862-693-99carisoprodol1000 in 1 BOTTLETABLET100017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-693CARISOPRODOL TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 5 package rows20240107_79637c7b-fe7b-436c-892b-6c36abfdcacc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730794carisoprodol 250 MG Oral TabletPSN79637c7b-fe7b-436c-892b-6c36abfdcacc17
197446carisoprodol 350 MG Oral TabletPSN79637c7b-fe7b-436c-892b-6c36abfdcacc17
730794carisoprodol 250 MG Oral TabletSCD79637c7b-fe7b-436c-892b-6c36abfdcacc17
197446carisoprodol 350 MG Oral TabletSCD79637c7b-fe7b-436c-892b-6c36abfdcacc17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-693-0165862069301100 TABLET in 1 BOTTLE (65862-693-01) 100 tablet2016-11-080000-00-00NoNoCurrent
65862-693-306586206933030 TABLET in 1 BOTTLE (65862-693-30) 30 tablet2016-11-080000-00-00NoNoCurrent
65862-693-59658620693595000 TABLET in 1 BAG (65862-693-59)5000 tablet08-NOV-16Current
65862-693-606586206936060 TABLET in 1 BOTTLE (65862-693-60) 60 tablet2016-11-080000-00-00NoNoCurrent
65862-693-906586206939090 TABLET in 1 BOTTLE (65862-693-90) 90 tablet2016-11-080000-00-00NoNoCurrent
65862-693-99658620693991000 TABLET in 1 BOTTLE (65862-693-99) 1000 tablet2016-11-080000-00-00NoNoCurrent