Orphenadrine Citrate
Orphenadrine Citrate
Approved
Approval ID
91436f1e-8b05-435c-e053-2a95a90ae21f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code61919-177
Application NumberANDA040284
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameOrphenadrine Citrate
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
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT