NDC 0168-0242

Diflorasone Diacetate

Diflorasone Diacetate

Diflorasone Diacetate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.. The primary component is Diflorasone Diacetate.

Product ID0168-0242_619c5e2e-9e32-4a4d-b36b-31e480a5be3d
NDC0168-0242
Product TypeHuman Prescription Drug
Proprietary NameDiflorasone Diacetate
Generic NameDiflorasone Diacetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1998-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA075187
Labeler NameE. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.
Substance NameDIFLORASONE DIACETATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0168-0242-60

60 g in 1 TUBE (0168-0242-60)
Marketing Start Date1998-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0242-15 [00168024215]

Diflorasone Diacetate CREAM
Marketing CategoryANDA
Application NumberANDA075187
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-03-30
Inactivation Date2020-01-31

NDC 0168-0242-30 [00168024230]

Diflorasone Diacetate CREAM
Marketing CategoryANDA
Application NumberANDA075187
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-03-30
Inactivation Date2020-01-31

NDC 0168-0242-60 [00168024260]

Diflorasone Diacetate CREAM
Marketing CategoryANDA
Application NumberANDA075187
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-03-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIFLORASONE DIACETATE.5 mg/g

OpenFDA Data

SPL SET ID:69ad2eb8-1d9b-4a4d-9b88-a5f4db0609d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966577
    • UPC Code
  • 0301680242156

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Diflorasone Diacetate" or generic name "Diflorasone Diacetate"

    NDCBrand NameGeneric Name
    0168-0242Diflorasone Diacetatediflorasone diacetate
    0168-0243Diflorasone DiacetateDiflorasone Diacetate
    0168-0353Diflorasone Diacetatediflorasone diacetate
    51672-1295Diflorasone DiacetateDiflorasone Diacetate
    51672-1296Diflorasone DiacetateDiflorasone Diacetate
    52565-063Diflorasone DiacetateDiflorasone Diacetate
    61748-350Diflorasone DiacetateDiflorasone Diacetate
    64980-124Diflorasone Diacetatediflorasone diacetate
    71800-009Diflorasone DiacetateDiflorasone Diacetate
    72919-549Diflorasone DiacetateDiflorasone Diacetate
    10337-395ApexiCon Ediflorasone diacetate
    62559-365ApexiCon Ediflorasone diacetate
    51672-5292psorconDiflorasone Diacetate
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