NDC 52565-005

Hydrocortisone

Hydrocortisone

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

Product ID52565-005_4cc0d9e7-5f6b-4a18-819c-069b63695131
NDC52565-005
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-07-27
Marketing CategoryANDA / ANDA
Application NumberANDA203804
Labeler NameTeligent Pharma, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52565-005-60

1 BOTTLE in 1 CARTON (52565-005-60) > 59 mL in 1 BOTTLE
Marketing Start Date2018-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-005-60 [52565000560]

Hydrocortisone LOTION
Marketing CategoryANDA
Application NumberANDA203804
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-27

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/mL

OpenFDA Data

SPL SET ID:5aacab36-0130-dc7b-92a5-dd288588d1d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197785

    • Pharmacological Class

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

    Medicade Reported Pricing

    52565005680 TRIAMCINOLONE 0.1% CREAM

    Pricing Unit: GM | Drug Type:

    52565005630 TRIAMCINOLONE 0.1% CREAM

    Pricing Unit: GM | Drug Type:

    52565005626 TRIAMCINOLONE 0.1% CREAM

    Pricing Unit: GM | Drug Type:

    52565005615 TRIAMCINOLONE 0.1% CREAM

    Pricing Unit: GM | Drug Type:

    52565005504 CLOBETASOL 0.05% TOPICAL LOTN

    Pricing Unit: ML | Drug Type:

    52565005502 CLOBETASOL 0.05% TOPICAL LOTN

    Pricing Unit: ML | Drug Type:

    52565005460 FLUOCINONIDE 0.05% GEL

    Pricing Unit: GM | Drug Type:

    52565005430 FLUOCINONIDE 0.05% GEL

    Pricing Unit: GM | Drug Type:

    52565005415 FLUOCINONIDE 0.05% GEL

    Pricing Unit: GM | Drug Type:

    52565005160 CLOBETASOL 0.05% CREAM

    Pricing Unit: GM | Drug Type:

    52565005145 CLOBETASOL 0.05% CREAM

    Pricing Unit: GM | Drug Type:

    52565005130 CLOBETASOL 0.05% CREAM

    Pricing Unit: GM | Drug Type:

    52565005115 CLOBETASOL 0.05% CREAM

    Pricing Unit: GM | Drug Type:

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

    NDCBrand NameGeneric Name
    0115-1696HYDROCORTISONEhydrocortisone
    0115-1697HYDROCORTISONEhydrocortisone
    0115-1700HYDROCORTISONEhydrocortisone
    0143-1252HydrocortisoneHydrocortisone
    0143-1253HydrocortisoneHydrocortisone
    0143-1254HydrocortisoneHydrocortisone
    0168-0014HYDROCORTISONEHYDROCORTISONE
    0168-0015hydrocortisoneHydrocortisone
    0168-0016HYDROCORTISONEHYDROCORTISONE
    0168-0020HydrocortisoneHydrocortisone
    0168-0080HydrocortisoneHydrocortisone
    0168-0146HydrocortisoneHydrocortisone
    0168-0154HYDROCORTISONEHYDROCORTISONE
    0168-0181HYDROCORTISONEHYDROCORTISONE
    0168-0288Hydrocortisonehydrocortisone
    67777-004HydrocortisoneHydrocortisone
    67777-224HydrocortisoneHydrocortisone
    67777-237HydrocortisoneHydrocortisone
    67777-415HydrocortisoneHydrocortisone
    67777-003HydrocortisoneHydrocortisone
    67777-417HydrocortisoneHydrocortisone
    68071-1844HYDROCORTISONEHYDROCORTISONE
    68071-1581HydrocortisoneHydrocortisone
    68071-4511HydrocortisoneHydrocortisone
    68071-4582HydrocortisoneHydrocortisone
    68084-789HydrocortisoneHydrocortisone
    68084-469HydrocortisoneHydrocortisone
    68151-4021HydrocortisoneHydrocortisone
    68151-2269HYDROCORTISONEHYDROCORTISONE
    68084-930HydrocortisoneHydrocortisone
    0472-0321HydrocortisoneHydrocortisone
    0472-0337HydrocortisoneHydrocortisone
    0498-0800HYDROCORTISONEHYDROCORTISONE
    68599-1182HydrocortisoneHydrocortisone
    68786-223HydrocortisoneHydrocortisone
    68786-224HydrocortisoneHydrocortisone
    68788-0645hydrocortisonehydrocortisone
    68788-9922HydrocortisoneHydrocortisone
    68788-9715HydrocortisoneHydrocortisone
    68788-9856HydrocortisoneHydrocortisone
    69396-003HydrocortisoneHydrocortisone
    69842-627hydrocortisonehydrocortisone
    70518-0143HydrocortisoneHydrocortisone
    70518-1360HydrocortisoneHydrocortisone
    0603-0535HydrocortisoneHydrocortisone
    0603-3901HydrocortisoneHydrocortisone
    0603-3900HydrocortisoneHydrocortisone
    0603-7781HydrocortisoneHydrocortisone
    0603-3899HydrocortisoneHydrocortisone
    71335-0812HydrocortisoneHydrocortisone
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.