Carac
(fluorouracil cream)
Approved
Approval ID
6795f2b1-1381-4a4f-ad34-2c28ebd1cfaf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2021
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorouracil
PRODUCT DETAILS
NDC Product Code0187-5200
Application NumberNDA020985
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateMay 17, 2021
Generic Namefluorouracil
INGREDIENTS (14)
fluorouracilActive
Quantity: 5 mg in 1 g
Code: U3P01618RT
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
methyl gluceth-20Inactive
Code: J3QD0LD11P
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT