Pranactin-Citric
Approved
Approval ID
571577b1-2160-4c2f-b953-062c15373fcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2009
Manufacturers
FDA
Otsuka America Pharmaceutical
DUNS: 008314390
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
UREA C-13
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59148-023
Application NumberNDA020586
Product Classification
M
Marketing Category
C73594
G
Generic Name
UREA C-13
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2009
FDA Product Classification
INGREDIENTS (4)
UREA C-13Active
Quantity: 75 mg in 3000 mg
Code: W6KX9E6D8X
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Quantity: 2000 mg in 3000 mg
Code: XF417D3PSL
Classification: IACT
MANNITOLInactive
Quantity: 775 mg in 3000 mg
Code: 3OWL53L36A
Classification: IACT
ASPARTAMEInactive
Quantity: 150 mg in 3000 mg
Code: Z0H242BBR1
Classification: IACT