Orphenadrine Citrate, Aspirin and Caffeine
Orphenadrine Citrate, Aspirin and Caffeine Tablets
Approved
Approval ID
8e41b33e-f71f-4a5e-b88f-cdfefb2bee20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 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.
Orphenadrine Citrate, Aspirin and Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-726
Application NumberANDA074654
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate, Aspirin and Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2010
FDA Product Classification
INGREDIENTS (13)
ORPHENADRINE CITRATEActive
Quantity: 50 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB
ASPIRINActive
Quantity: 770 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 60 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT