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Carisoprodol

911 Carisoprodol 350 mg These highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets, for oral use CIV Initial U.S. Approval: 1959

Approved
Approval ID

59b8db2c-dbc3-d6d7-e053-2991aa0a07dd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 21, 2017

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carisoprodol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-911
Application NumberANDA040245
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2017
FDA Product Classification

INGREDIENTS (5)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARISOPRODOLActive
Quantity: 350 mg in 1 1
Code: 21925K482H
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT

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