NDC 0187-5200

Carac

Fluorouracil

Carac is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Fluorouracil.

• Product ID: 0187-5200_8fb0477d-5bf9-482f-9b73-e19cdced9571
• NDC: 0187-5200
• Product Type: Human Prescription Drug
• Proprietary Name: Carac
• Generic Name: Fluorouracil
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-06-28
• Marketing Category: NDA / NDA
• Application Number: NDA020985
• Labeler Name: Bausch Health US LLC
• Substance Name: FLUOROURACIL
• Active Ingredient Strength: 5 mg/g
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0187-5200-30

1 TUBE in 1 CARTON (0187-5200-30) > 30 g in 1 TUBE

• Marketing Start Date: 2013-06-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-5200-30 [00187520030]

Carac CREAM

• Marketing Category: NDA
• Application Number: NDA020985
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2013-06-28

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROURACIL	5 mg/g

OpenFDA Data

• SPL SET ID: 6795f2b1-1381-4a4f-ad34-2c28ebd1cfaf
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • U3P01618RT
• RxNorm Concept Unique ID - RxCUI:
  • 284539
  • 284191

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0187-5200	Carac	fluorouracil
0703-3015	Adrucil	Fluorouracil
0703-3018	Adrucil	Fluorouracil
0703-3019	Adrucil	Fluorouracil
0187-3204	Efudex	Fluorouracil
16110-812	Fluoroplex	fluorouracil
0378-4791	Fluorouracil	Fluorouracil
16714-178	Fluorouracil	Fluorouracil
16729-276	Fluorouracil	Fluorouracil
16729-542	Fluorouracil	Fluorouracil
21695-829	FLUOROURACIL	fluorouracil
25021-215	fluorouracil	fluorouracil
0378-8078	Fluorouracil Cream	fluorouracil