NDC 52565-063

Diflorasone Diacetate

Diflorasone Diacetate

Diflorasone Diacetate is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Diflorasone Diacetate.

Product ID52565-063_3d24f1b4-101c-4b4d-b797-7e9e24d16bb6
NDC52565-063
Product TypeHuman Prescription Drug
Proprietary NameDiflorasone Diacetate
Generic NameDiflorasone Diacetate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2018-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA210753
Labeler NameTeligent Pharma, 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 52565-063-15

1 TUBE in 1 CARTON (52565-063-15) > 15 g in 1 TUBE
Marketing Start Date2018-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-063-30 [52565006330]

Diflorasone Diacetate OINTMENT
Marketing CategoryANDA
Application NumberANDA210753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-06-13

NDC 52565-063-60 [52565006360]

Diflorasone Diacetate OINTMENT
Marketing CategoryANDA
Application NumberANDA210753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-06-13

NDC 52565-063-15 [52565006315]

Diflorasone Diacetate OINTMENT
Marketing CategoryANDA
Application NumberANDA210753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-06-13

Drug Details

Active Ingredients

IngredientStrength
DIFLORASONE DIACETATE.5 mg/g

OpenFDA Data

SPL SET ID:20b7f7d9-bf45-4533-8173-6f1650388c66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 966607

    • 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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