NDC 0187-5115

Ertaczo

Sertaconazole Nitrate

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

• Product ID: 0187-5115_36e61499-51ad-48aa-a330-0b99df184bcf
• NDC: 0187-5115
• Product Type: Human Prescription Drug
• Proprietary Name: Ertaczo
• Generic Name: Sertaconazole Nitrate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2003-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA021385
• Labeler Name: Bausch Health US LLC
• Substance Name: SERTACONAZOLE NITRATE
• Active Ingredient Strength: 20 mg/g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0187-5115-60

1 TUBE in 1 CARTON (0187-5115-60) > 60 g in 1 TUBE

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

NDC SPL Data Element Entries

NDC 0187-5115-02 [00187511502]

Ertaczo CREAM

• Marketing Category: NDA
• Application Number: NDA021385
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-12-10

NDC 0187-5115-60 [00187511560]

Ertaczo CREAM

• Marketing Category: NDA
• Application Number: NDA021385
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2003-12-10

Drug Details

Active Ingredients

Ingredient	Strength
SERTACONAZOLE NITRATE	20 mg/g

OpenFDA Data

• SPL SET ID: 821073f7-33f6-464d-baed-f66d97987d6d
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 1DV05410M5
• RxNorm Concept Unique ID - RxCUI:
  • 580294
  • 250511

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "Ertaczo" or generic name "Sertaconazole Nitrate"

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