NDC 0517-0420

ESTRADIOL VALERATE

Estradiol Valerate

ESTRADIOL VALERATE is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Estradiol Valerate.

Product ID0517-0420_34294770-179c-4b76-b20f-9e842e156851
NDC0517-0420
Product TypeHuman Prescription Drug
Proprietary NameESTRADIOL VALERATE
Generic NameEstradiol Valerate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2020-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA090920
Labeler NameAmerican Regent, Inc.
Substance NameESTRADIOL VALERATE
Active Ingredient Strength20 mg/mL
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0517-0420-01

1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2020-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0420-01 [00517042001]

ESTRADIOL VALERATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090920
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-01

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL VALERATE20 mg/mL

OpenFDA Data

SPL SET ID:2984bce2-89bf-4768-a1ca-ccf03b1197be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310190
  • 310191
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ESTRADIOL VALERATE" or generic name "Estradiol Valerate"

    NDCBrand NameGeneric Name
    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
    42023-110Delestrogenestradiol valerate
    42023-111Delestrogenestradiol valerate
    42023-112Delestrogenestradiol valerate

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