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
NDC Product Code63187-632
Application NumberANDA040327
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 1, 2019
Generic NameOrphenadrine Citrate
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