NDC 62559-111

Cortenema

Hydrocortisone

Cortenema is a Rectal Enema in the Human Prescription Drug category. It is labeled and distributed by Ani Pharmaceuticals, Inc.. The primary component is Hydrocortisone.

Product ID62559-111_54dcdbdd-ff40-4ed2-8298-fc61dddf0934
NDC62559-111
Product TypeHuman Prescription Drug
Proprietary NameCortenema
Generic NameHydrocortisone
Dosage FormEnema
Route of AdministrationRECTAL
Marketing Start Date2012-08-10
Marketing CategoryNDA / NDA
Application NumberNDA016199
Labeler NameANI Pharmaceuticals, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength100 mg/60mL
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 62559-111-07

7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) > 60 mL in 1 BOTTLE, UNIT-DOSE
Marketing Start Date2012-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62559-111-07 [62559011107]

Cortenema ENEMA
Marketing CategoryNDA
Application NumberNDA016199
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-10

NDC 62559-111-11 [62559011111]

Cortenema ENEMA
Marketing CategoryNDA
Application NumberNDA016199
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-10

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE100 mg/60mL

OpenFDA Data

SPL SET ID:a307448a-ccc4-41a8-977a-11f28f0bded9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 102250
  • 310878

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    62559-111CortenemaCortenema
    0096-0732Aquanil HCHydrocortisone
    0113-0793basic care hydrocortisonehydrocortisone
    0113-7369basic care hydrocortisoneHydrocortisone
    0113-7006Basic Case Hydrocortisone Anti-Itchhydrocortisone
    0009-0012CORTEFhydrocortisone
    0009-0031CORTEFhydrocortisone
    0009-0044CORTEFhydrocortisone
    0113-0471Good Sense Anti Itchhydrocortisone
    0113-0541good sense anti itchHydrocortisone
    0113-0973Good Sense Anti Itchhydrocortisone
    0113-1369good sense anti itchHydrocortisone
    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

    Trademark Results [Cortenema]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CORTENEMA
    CORTENEMA
    72226791 0808375 Live/Registered
    ROWELL LABORATORIES, INC.
    1965-08-30
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