NDC 0168-0278

Amcinonide

Amcinonide

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

Product ID0168-0278_1a90b281-f4ff-4798-b217-a531a280a77b
NDC0168-0278
Product TypeHuman Prescription Drug
Proprietary NameAmcinonide
Generic NameAmcinonide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2003-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA076065
Labeler NameFougera Pharmaceuticals Inc.
Substance NameAMCINONIDE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0168-0278-15

1 TUBE in 1 CARTON (0168-0278-15) > 15 g in 1 TUBE
Marketing Start Date2003-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0278-30 [00168027830]

Amcinonide CREAM
Marketing CategoryANDA
Application NumberANDA076065
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2003-05-15

NDC 0168-0278-15 [00168027815]

Amcinonide CREAM
Marketing CategoryANDA
Application NumberANDA076065
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2003-05-15

NDC 0168-0278-60 [00168027860]

Amcinonide CREAM
Marketing CategoryANDA
Application NumberANDA076065
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2003-05-15

Drug Details

Active Ingredients

IngredientStrength
AMCINONIDE1 mg/g

OpenFDA Data

SPL SET ID:8aefa477-ac2c-41c8-a807-d24522aed8f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197327
  • UPC Code
  • 0301680278155
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0168-0278AmcinonideAmcinonide
    0168-0279Amcinonideamcinonide
    0168-0280amcinonideamcinonide
    51672-4054AmcinonideAmcinonide
    51672-4060AmcinonideAmcinonide

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