Orphenadrine Citrate
Orphenadrine Citrate Extended-Release Tablets
Approved
Approval ID
37e6a157-5d0d-4887-9a26-ed5521fb08e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-632
Application NumberANDA040327
Product Classification
M
Marketing Category
C73584
G
Generic Name
Orphenadrine Citrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification
INGREDIENTS (4)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ORPHENADRINE CITRATEActive
Quantity: 100 mg in 1 1
Code: X0A40N8I4S
Classification: ACTIB