NDC 51662-1261

SOLU-CORTEF

Solu-cortef

SOLU-CORTEF is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co. Llc, Dba Healthfirst. The primary component is Hydrocortisone Sodium Succinate.

Product ID51662-1261_74f84173-a440-7788-e053-2991aa0a8fb2
NDC51662-1261
Product TypeHuman Prescription Drug
Proprietary NameSOLU-CORTEF
Generic NameSolu-cortef
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-09-03
Marketing CategoryNDA / NDA
Application NumberNDA009866
Labeler NameHF Acquisition Co. LLC, DBA HealthFirst
Substance NameHYDROCORTISONE SODIUM SUCCINATE
Active Ingredient Strength100 mg/2mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1261-1

2 mL in 1 VIAL, SINGLE-DOSE (51662-1261-1)
Marketing Start Date2018-09-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1261-1 [51662126101]

SOLU-CORTEF INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA009866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-03
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE SODIUM SUCCINATE100 mg/2mL

OpenFDA Data

SPL SET ID:74f84173-a43f-7788-e053-2991aa0a8fb2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238755

    • Pharmacological Class

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

    NDC Crossover Matching brand name "SOLU-CORTEF" or generic name "Solu-cortef"

    NDCBrand NameGeneric Name
    0009-0005Solu-Cortefhydrocortisone sodium succinate
    0009-0011Solu-Cortefhydrocortisone sodium succinate
    0009-0013Solu-Cortefhydrocortisone sodium succinate
    0009-0016Solu-Cortefhydrocortisone sodium succinate
    0009-0825Solu-Cortefhydrocortisone sodium succinate
    51662-1261SOLU-CORTEFSOLU-CORTEF
    51662-1262SOLU-CORTEFSOLU-CORTEF
    55154-3942Solu-Cortefhydrocortisone sodium succinate

    Trademark Results [SOLU-CORTEF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOLU-CORTEF
    SOLU-CORTEF
    71692184 0632542 Live/Registered
    UPJOHN COMPANY, THE
    1955-07-29
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