NDC 50742-423

FLUOROURACIL

Fluorouracil

FLUOROURACIL is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Fluorouracil.

Product ID50742-423_444ffac6-2f8d-41e1-be72-a8b4be7c4bfc
NDC50742-423
Product TypeHuman Prescription Drug
Proprietary NameFLUOROURACIL
Generic NameFluorouracil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-12-21
Marketing CategoryANDA / ANDA
Application NumberANDA209219
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameFLUOROURACIL
Active Ingredient Strength50 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50742-423-10

1 VIAL in 1 CARTON (50742-423-10) > 10 mL in 1 VIAL
Marketing Start Date2019-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-423-10 [50742042310]

FLUOROURACIL INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209219
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-21

Drug Details

Active Ingredients

IngredientStrength
FLUOROURACIL50 mg/mL

Pharmacological Class

  • Nucleic Acid Synthesis Inhibitors [MoA]
  • Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "FLUOROURACIL" or generic name "Fluorouracil"

NDCBrand NameGeneric Name
0378-4791FluorouracilFluorouracil
16714-178FluorouracilFluorouracil
16729-276FluorouracilFluorouracil
16729-542FluorouracilFluorouracil
21695-829FLUOROURACILfluorouracil
25021-215fluorouracilfluorouracil
68001-266FluorouracilFluorouracil
68083-293FluorouracilFluorouracil
68083-292FluorouracilFluorouracil
68083-269FluorouracilFluorouracil
68083-270FluorouracilFluorouracil
43547-259FluorouracilFluorouracil
43547-258FluorouracilFluorouracil
51672-4063FluorouracilFluorouracil
51672-4062FluorouracilFluorouracil
51672-4118FluorouracilFluorouracil
52549-4118FluorouracilFluorouracil
63323-117FluorouracilFluorouracil
66758-044FluorouracilFluorouracil
66758-054FluorouracilFluorouracil
66530-249FLUOROURACILFLUOROURACIL
66530-258FluorouracilFluorouracil
50090-4264FluorouracilFluorouracil
51862-362FLUOROURACILFLUOROURACIL
50742-483FLUOROURACILFLUOROURACIL
50742-481FLUOROURACILFLUOROURACIL
50742-423FLUOROURACILFLUOROURACIL
50742-482FLUOROURACILFLUOROURACIL
0703-3015AdrucilFluorouracil
0703-3018AdrucilFluorouracil
0703-3019AdrucilFluorouracil
0187-5200Caracfluorouracil
0187-3204EfudexFluorouracil
16110-812Fluoroplexfluorouracil
0378-8078Fluorouracil Creamfluorouracil
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