NDC 16110-812

Fluoroplex

Fluorouracil

Fluoroplex is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Fluorouracil.

• Product ID: 16110-812_0d7ce07c-d2a5-4d78-adb9-c7196c6cb3a4
• NDC: 16110-812
• Product Type: Human Prescription Drug
• Proprietary Name: Fluoroplex
• Generic Name: Fluorouracil
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 1993-12-03
• Marketing Category: NDA / NDA
• Application Number: NDA016988
• Labeler Name: Almirall, LLC
• Substance Name: FLUOROURACIL
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 16110-812-30

1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE

• Marketing Start Date: 1993-12-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-812-30 [16110081230]

Fluoroplex CREAM

• Marketing Category: NDA
• Application Number: NDA016988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1993-12-03

Drug Details

Active Ingredients

Ingredient	Strength
FLUOROURACIL	10 mg/g

OpenFDA Data

• SPL SET ID: 258bb79a-56b3-4f46-ade6-7331ec031074
• Manufacturer:
  • Aqua Pharmaceuticals, LLC
• UNII:
  • U3P01618RT
• RxNorm Concept Unique ID - RxCUI:
  • 197709
  • 92752

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
16110-812	Fluoroplex	fluorouracil
0703-3015	Adrucil	Fluorouracil
0703-3018	Adrucil	Fluorouracil
0703-3019	Adrucil	Fluorouracil
0187-5200	Carac	fluorouracil
0187-3204	Efudex	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