NDC 0378-8056

Halcinonide

Halcinonide

Halcinonide is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Halcinonide.

Product ID0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3b
NDC0378-8056
Product TypeHuman Prescription Drug
Proprietary NameHalcinonide
Generic NameHalcinonide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA211027
Labeler NameMylan Pharmaceuticals Inc.
Substance NameHALCINONIDE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8056-49

1 TUBE in 1 CARTON (0378-8056-49) > 30 g in 1 TUBE
Marketing Start Date2019-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8056-60 [00378805660]

Halcinonide CREAM
Marketing CategoryANDA
Application NumberANDA211027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-08-15

NDC 0378-8056-49 [00378805649]

Halcinonide CREAM
Marketing CategoryANDA
Application NumberANDA211027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-08-15

Drug Details

Active Ingredients

IngredientStrength
HALCINONIDE1 mg/g

OpenFDA Data

SPL SET ID:b7d78c72-a683-4208-b7dd-5523502c036c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 103467

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Halcinonide" or generic name "Halcinonide"

    NDCBrand NameGeneric Name
    0378-8056HalcinonideHalcinonide
    57664-698HALCINONIDEHALCINONIDE
    71428-011HalcinonideHalcinonide
    0003-0249HALOGHalcinonide
    10631-096HALOGHALCINONIDE
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