ORPHENADRINE CITRATE
Orphenadrine Citrate Extended-Release Tablets
Approved
Approval ID
28d5753e-862a-4811-8b9f-6707361f8475
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
orphenadrine citrate
PRODUCT DETAILS
NDC Product Code54868-4102
Application NumberANDA040284
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 12, 2011
Generic Nameorphenadrine citrate
INGREDIENTS (4)
ORPHENADRINE CITRATEActive
Quantity: 100 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT