NDC 0115-1518

Estradiol Vaginal

Estradiol

Estradiol Vaginal is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Estradiol.

Product ID0115-1518_09d667d1-2e60-4f0b-ab98-e1aae1c90b50
NDC0115-1518
Product TypeHuman Prescription Drug
Proprietary NameEstradiol Vaginal
Generic NameEstradiol
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2018-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA210194
Labeler NameImpax Generics
Substance NameESTRADIOL
Active Ingredient Strength0 mg/g
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0115-1518-66

1 TUBE in 1 CARTON (0115-1518-66) > 42.5 g in 1 TUBE
Marketing Start Date2018-03-14
Marketing End Date2022-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1518-66 [00115151866]

Estradiol Vaginal CREAM
Marketing CategoryANDA
Application NumberANDA210194
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-03-14

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.1 mg/g

OpenFDA Data

SPL SET ID:b69cacf1-3265-4df7-8d83-df4b4a43a103
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310169
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Estradiol Vaginal" or generic name "Estradiol"

    NDCBrand NameGeneric Name
    0115-1518Estradiol VaginalEstradiol Vaginal
    42291-426Estradiol VaginalEstradiol Vaginal
    45802-097Estradiol VaginalEstradiol Vaginal
    0023-5885AloraEstradiol
    0023-5886AloraEstradiol
    0023-5887AloraEstradiol
    0023-5888AloraEstradiol
    0037-4801ELESTRINESTRADIOL
    0037-4802ELESTRINESTRADIOL
    0013-2150Estringestradiol
    0078-0343Vivelle-Dotestradiol
    0078-0344Vivelle-Dotestradiol
    0078-0345Vivelle-Dotestradiol
    0078-0346Vivelle-Dotestradiol
    0078-0365Vivelle-Dotestradiol

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.