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Carisoprodol and Aspirin

CARISOPRODOL AND ASPIRIN 200MG/325MG USP Rx Only

Approved
Approval ID

e4c5e195-e3f1-487a-accd-c2c6fbbd7837

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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

Carisoprodol and Aspirin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-570
Application NumberANDA040116
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carisoprodol and Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2010
FDA Product Classification

INGREDIENTS (11)

ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CARISOPRODOLActive
Quantity: 200 mg in 1 1
Code: 21925K482H
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

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Carisoprodol and Aspirin - FDA Drug Approval Details