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 ID0187-5115_36e61499-51ad-48aa-a330-0b99df184bcf
NDC0187-5115
Product TypeHuman Prescription Drug
Proprietary NameErtaczo
Generic NameSertaconazole Nitrate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2003-12-10
Marketing CategoryNDA / NDA
Application NumberNDA021385
Labeler NameBausch Health US LLC
Substance NameSERTACONAZOLE NITRATE
Active Ingredient Strength20 mg/g
Pharm ClassesAzole Antifungal [EPC],Azoles [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-5115-60

1 TUBE in 1 CARTON (0187-5115-60) > 60 g in 1 TUBE
Marketing Start Date2003-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5115-02 [00187511502]

Ertaczo CREAM
Marketing CategoryNDA
Application NumberNDA021385
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-12-10

NDC 0187-5115-60 [00187511560]

Ertaczo CREAM
Marketing CategoryNDA
Application NumberNDA021385
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2003-12-10

Drug Details

Active Ingredients

IngredientStrength
SERTACONAZOLE NITRATE20 mg/g

OpenFDA Data

SPL SET ID:821073f7-33f6-464d-baed-f66d97987d6d
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0187-5115ErtaczoSertaconazole Nitrate
    21695-454ERTACZOERTACZO

    Trademark Results [Ertaczo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ERTACZO
    ERTACZO
    78125990 2893833 Live/Registered
    VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
    2002-05-03

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