Oxybutynin Chloride
OXYBUTYNIN CHLORIDE SYRUP, USP 5 mg/5 mL
Approved
Approval ID
43cb979d-b532-43cf-9cd9-de66ebb6a539
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2018
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxybutynin Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-9200
Application NumberANDA074868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxybutynin Chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2012
FDA Product Classification
INGREDIENTS (11)
OXYBUTYNIN CHLORIDEActive
Quantity: 5 mg in 5 mL
Code: L9F3D9RENQ
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT