Orphenadrine Citrate
Orphenadrine CitrateExtended-release Tablets, 100 mg
Approved
Approval ID
b0a4eb39-ec35-4e60-99c2-422ef5287585
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 11, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-527
Application NumberANDA040368
Product Classification
M
Marketing Category
C73584
G
Generic Name
ORPHENADRINE CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (4)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ORPHENADRINE CITRATEActive
Quantity: 100 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT