ORPHENADRINE CITRATE
Orphenadrine Citrate Extended-release Tablets, 100 mg
Approved
Approval ID
942ef941-eb4e-4b27-8c79-b2d9ec129641
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-559
Application NumberANDA040368
Product Classification
M
Marketing Category
C73584
G
Generic Name
ORPHENADRINE CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2012
FDA Product Classification
INGREDIENTS (5)
ORPHENADRINE CITRATEActive
Quantity: 100 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT