NDC 0023-4857

VANIQA

Eflornithine Hydrochloride

VANIQA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Eflornithine Hydrochloride.

• Product ID: 0023-4857_52ae00fb-248c-4676-b643-b0a0636567a1
• NDC: 0023-4857
• Product Type: Human Prescription Drug
• Proprietary Name: VANIQA
• Generic Name: Eflornithine Hydrochloride
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA021145
• Labeler Name: Allergan, Inc.
• Substance Name: EFLORNITHINE HYDROCHLORIDE
• Active Ingredient Strength: 139 mg/g
• Pharm Classes: Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0023-4857-45

1 TUBE in 1 CARTON (0023-4857-45) > 45 g in 1 TUBE

• Marketing Start Date: 2013-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-4857-45 [00023485745]

VANIQA CREAM

• Marketing Category: NDA
• Application Number: NDA021145
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2013-06-01

Drug Details

Active Ingredients

Ingredient	Strength
EFLORNITHINE HYDROCHLORIDE	139 mg/g

OpenFDA Data

• SPL SET ID: e872db73-7cd7-4886-9b0f-6710700e3765
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 4NH22NDW9H
• RxNorm Concept Unique ID - RxCUI:
  • 284430
  • 313975

Pharmacological Class

• Antiprotozoal [EPC]
• Decarboxylase Inhibitor [EPC]
• Decarboxylase Inhibitors [MoA]
• Antiprotozoal [EPC]
• Decarboxylase Inhibitor [EPC]
• Decarboxylase Inhibitors [MoA]

NDC Crossover Matching brand name "VANIQA" or generic name "Eflornithine Hydrochloride"

NDC	Brand Name	Generic Name
0023-4857	VANIQA	eflornithine hydrochloride
82160-125	Florexa	Eflornithine Hydrochloride