FDA.reportPublic FDA data

CARISOPRODOL

Product NDC
76420-646
11-digit product format
764200646
Labeler code
76420
Product ID
76420-646_0b44d519-3a0a-614d-e063-6294a90ab9b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARISOPRODOL
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA203374
Marketing category
ANDA
Marketing start
2014-01-27
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

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
76420-646-01CARISOPRODOL100 in 1 BOTTLETABLET1001
76420-646-30CARISOPRODOL30 in 1 BOTTLETABLET301
76420-646-60CARISOPRODOL60 in 1 BOTTLETABLET601
76420-646-90CARISOPRODOL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-646-01EA - Each76420-6463fd5664a-bded-4760-be5d-a32284b791fb12024-01-04
76420-646-30EA - Each76420-64691c0a1dc-8af0-49ef-a96e-352f3e4b52aa12024-01-04
76420-646-60EA - Each76420-64698434493-6189-4ced-9120-0881c79878c912024-01-04
76420-646-90EA - Each76420-646ea8157e6-c17a-4bfc-be69-f08c61eb318012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-646CARISOPRODOL TABLET [ASCLEMED USA, INC.]1Current NDC, 4 package rows20231201_4221d7d1-d7d6-46c4-be41-8c8e99129324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN4221d7d1-d7d6-46c4-be41-8c8e991293241
197446carisoprodol 350 MG Oral TabletSCD4221d7d1-d7d6-46c4-be41-8c8e991293241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-646-0176420064601100 TABLET in 1 BOTTLE (76420-646-01) 100 tablet2023-11-29NoNoHistorical
76420-646-307642006463030 TABLET in 1 BOTTLE (76420-646-30) 30 tablet2023-11-29NoNoHistorical
76420-646-607642006466060 TABLET in 1 BOTTLE (76420-646-60) 60 tablet2023-11-29NoNoHistorical
76420-646-907642006469090 TABLET in 1 BOTTLE (76420-646-90) 90 tablet2023-11-29NoNoHistorical