NDC 52565-004

Hydrocortisone

Hydrocortisone

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

Product ID52565-004_4e850fa2-2bb2-4291-9b1d-6f03fcfcf15c
NDC52565-004
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-07-23
Marketing CategoryANDA / ANDA
Application NumberANDA203810
Labeler NameTeligent Pharma, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52565-004-26

1 JAR in 1 CARTON (52565-004-26) > 453.6 g in 1 JAR
Marketing Start Date2018-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-004-26 [52565000426]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA203810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-23

NDC 52565-004-30 [52565000430]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA203810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-23

NDC 52565-004-16 [52565000416]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA203810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-23
Marketing End Date2019-07-29

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:bc7651e9-e7c7-49e0-ad64-36eb50d3eaa2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310891

    • Pharmacological Class

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

    Medicade Reported Pricing

    52565004815 TRIAMCINOLONE 0.5% OINTMENT

    Pricing Unit: GM | Drug Type:

    52565004260 NYSTATIN-TRIAMCINOLONE OINTM

    Pricing Unit: GM | Drug Type:

    52565004230 NYSTATIN-TRIAMCINOLONE OINTM

    Pricing Unit: GM | Drug Type:

    52565004215 NYSTATIN-TRIAMCINOLONE OINTM

    Pricing Unit: GM | Drug Type:

    52565004060 FLUOCINONIDE 0.05% OINTMENT

    Pricing Unit: GM | Drug Type:

    52565004030 FLUOCINONIDE 0.05% OINTMENT

    Pricing Unit: GM | Drug Type:

    52565004015 FLUOCINONIDE 0.05% OINTMENT

    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
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