Orphenadrine Citrate
Orphenadrine Citrate Extended-Release Tablets
Approved
Approval ID
19b31a8f-d07e-43df-a0f0-a9b34406c904
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2012
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-088
Application NumberANDA040284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2012
FDA Product Classification
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