NDC 42023-110

Delestrogen

Estradiol Valerate

Delestrogen is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Estradiol Valerate.

Product ID42023-110_132be116-35a8-467c-8e9e-da721c2bcf0d
NDC42023-110
Product TypeHuman Prescription Drug
Proprietary NameDelestrogen
Generic NameEstradiol Valerate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2007-11-01
Marketing CategoryNDA / NDA
Application NumberNDA009402
Labeler NamePar Pharmaceutical, Inc.
Substance NameESTRADIOL VALERATE
Active Ingredient Strength10 mg/mL
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42023-110-01

5 mL in 1 VIAL, MULTI-DOSE (42023-110-01)
Marketing Start Date2007-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42023-110-01 [42023011001]

Delestrogen INJECTION
Marketing CategoryNDA
Application NumberNDA009402
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-11-01

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL VALERATE10 mg/mL

OpenFDA Data

SPL SET ID:e8f94df9-0692-4462-a7f0-fe019a0a3f07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 206620
  • 310190
  • 310191
  • 206813
  • 206715
  • 310189

    • Pharmacological Class

    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Delestrogen" or generic name "Estradiol Valerate"

    NDCBrand NameGeneric Name
    42023-110Delestrogenestradiol valerate
    42023-111Delestrogenestradiol valerate
    42023-112Delestrogenestradiol valerate
    0143-9289Estradiol ValerateEstradiol Valerate
    0143-9290Estradiol ValerateEstradiol Valerate
    0143-9291Estradiol ValerateEstradiol Valerate
    0517-0420ESTRADIOL VALERATEESTRADIOL VALERATE
    0517-0440ESTRADIOL VALERATEESTRADIOL VALERATE
    0574-0870ESTRADIOL VALERATEESTRADIOL VALERATE
    0574-0872ESTRADIOL VALERATEESTRADIOL VALERATE

    Trademark Results [Delestrogen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DELESTROGEN
    DELESTROGEN
    71677901 0619356 Live/Registered
    OLIN MATHIESON CHEMICAL CORPORATION
    1954-12-07
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.