FDA.reportPublic FDA data

carisoprodol

Product NDC
76420-853
11-digit product format
764200853
Labeler code
76420
Product ID
76420-853_21e58fc9-d824-4d1d-e063-6294a90a2acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA040792
Marketing category
ANDA
Marketing start
2009-08-06
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
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
CARISOPRODOL350 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
76420-853-00carisoprodol1000 in 1 BOTTLETABLET10001
76420-853-01carisoprodol100 in 1 BOTTLETABLET1001
76420-853-05carisoprodol500 in 1 BOTTLETABLET5001
76420-853-30carisoprodol30 in 1 BOTTLETABLET301
76420-853-60carisoprodol60 in 1 BOTTLETABLET601
76420-853-90carisoprodol90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-853CARISOPRODOL TABLET [ASCLEMED USA, INC.]1Current NDC, 6 package rows20240915_301f5e6a-54e1-4885-b9cb-de475de59b22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730794carisoprodol 250 MG Oral TabletPSN301f5e6a-54e1-4885-b9cb-de475de59b221
197446carisoprodol 350 MG Oral TabletPSN301f5e6a-54e1-4885-b9cb-de475de59b221
730794carisoprodol 250 MG Oral TabletSCD301f5e6a-54e1-4885-b9cb-de475de59b221
197446carisoprodol 350 MG Oral TabletSCD301f5e6a-54e1-4885-b9cb-de475de59b221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-853-00764200853001000 TABLET in 1 BOTTLE (76420-853-00) 1000 tablet2024-09-12NoNoHistorical
76420-853-0176420085301100 TABLET in 1 BOTTLE (76420-853-01) 100 tablet2024-09-12NoNoHistorical
76420-853-0576420085305500 TABLET in 1 BOTTLE (76420-853-05) 500 tablet2024-09-12NoNoHistorical
76420-853-307642008533030 TABLET in 1 BOTTLE (76420-853-30) 30 tablet2024-09-12NoNoHistorical
76420-853-607642008536060 TABLET in 1 BOTTLE (76420-853-60) 60 tablet2024-09-12NoNoHistorical
76420-853-907642008539090 TABLET in 1 BOTTLE (76420-853-90) 90 tablet2024-09-12NoNoHistorical