FDA.reportPublic FDA data

Carisoprodol

Product NDC
33261-387
11-digit product format
332610387
Labeler code
33261
Product ID
33261-387_8b551ae6-9f3a-4ff2-b62d-e74d5e6fe9a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040124
Marketing category
ANDA
Marketing start
2010-08-30
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
2019-12-31
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
33261-387-602020-01-31C16284748780-19d75b9cf-f8b4-f424-e053-dadaa90a57ceCarisoprodol Tablets, USP C-IV Rx Only These highlights do not include all the information needed to use Carisoprodol Tablets safely and effectively. See full prescribing information for Carisoprodol Tablets. Carisioprodol Tablets, USP for Oral Use. Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-387-60Carisoprodol60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-387-60EA - Each33261-387bde9c97d-2035-44ac-b9b6-89f44657922b12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARISOPRODOLACTIVE INGREDIENT21925K482HCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CARISOPRODOLACTIVE MOIETY21925K482HCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-387CARISOPRODOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20120831_11f93bdb-0855-4609-b6e4-700f10a639af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSN11f93bdb-0855-4609-b6e4-700f10a639af1
197446carisoprodol 350 MG Oral TabletSCD11f93bdb-0855-4609-b6e4-700f10a639af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-387-603326103876060 in 1 BOTTLE, PLASTICHistorical