NDC 21695-454

ERTACZO

Ertaczo

ERTACZO is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Sertaconazole Nitrate.

• Product ID: 21695-454_430b8bbe-96e2-4300-af13-a0704ac11076
• NDC: 21695-454
• Product Type: Human Prescription Drug
• Proprietary Name: ERTACZO
• Generic Name: Ertaczo
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2003-12-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA021385
• Labeler Name: Rebel Distributors Corp.
• Substance Name: SERTACONAZOLE NITRATE
• Active Ingredient Strength: 20 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-454-30

30 g in 1 TUBE (21695-454-30)

• Marketing Start Date: 2003-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-454-30 [21695045430]

ERTACZO CREAM

• Marketing Category: ANDA
• Application Number: ANDA021385
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-12-10
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
SERTACONAZOLE NITRATE	20 mg/g

OpenFDA Data

• SPL SET ID: 2e11cbfd-47c8-4d0f-ac7d-0beca0ea58aa
• Manufacturer:
  • Rebel Distributors Corp.
• UNII:
  • 1DV05410M5
• RxNorm Concept Unique ID - RxCUI:
  • 250511

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "ERTACZO" or generic name "Ertaczo"

NDC	Brand Name	Generic Name
0187-5115	Ertaczo	Sertaconazole Nitrate
21695-454	ERTACZO	ERTACZO