NDC 0168-0080

Hydrocortisone

Hydrocortisone

Hydrocortisone 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 Hydrocortisone.

Product ID0168-0080_b70bed43-6eed-4355-90b5-9d0819c13ebd
NDC0168-0080
Product TypeHuman Prescription Drug
Proprietary NameHydrocortisone
Generic NameHydrocortisone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date1986-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA089414
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength25 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0168-0080-16

454 g in 1 JAR (0168-0080-16)
Marketing Start Date1996-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0080-16 [00168008016]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA089414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-12-16

NDC 0168-0080-31 [00168008031]

Hydrocortisone CREAM
Marketing CategoryANDA
Application NumberANDA089414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1986-12-16

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

OpenFDA Data

SPL SET ID:bcd103f3-3dc8-4394-b8fd-8f8ddb721f77
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310891
  • 103401
    • UPC Code
  • 0301680080314
  • 0301680146300

    • 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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