Orphenadrine Citrate
Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.
Approved
Approval ID
59000b66-166e-75d2-e053-2a91aa0af3c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
St. Mary's Medical Park Pharmacy
DUNS: 063050751
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 Code60760-810
Application NumberANDA040284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (4)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ORPHENADRINE CITRATEActive
Quantity: 100 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB