NDC 0316-0186

Hydrocortisone

Hydrocortisone

Hydrocortisone is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Crown Laboratories. The primary component is Hydrocortisone.

Product ID0316-0186_6321732f-a99c-5782-e053-2a91aa0a17f1
NDC0316-0186
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1973-03-09
Marketing CategoryANDA / ANDA
Application NumberANDA080706
Labeler NameCrown Laboratories
Substance NameHYDROCORTISONE
Active Ingredient Strength10 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0316-0186-01

1 TUBE in 1 CARTON (0316-0186-01) > 28.4 g in 1 TUBE
Marketing Start Date1973-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0316-0186-16 [00316018616]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-01-02

NDC 0316-0186-03 [00316018603]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-08
Marketing End Date2017-10-26

NDC 0316-0186-01 [00316018601]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA080706
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1973-03-09

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE10 mg/g

OpenFDA Data

SPL SET ID:a84830ad-73dc-4a2e-b987-0a1103526535
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310891
  • 106258
    • UPC Code
  • 0303160193309
  • 0303160186011

    • Pharmacological Class

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

    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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