NDC 45802-097

Estradiol Vaginal

Estradiol

Estradiol Vaginal is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Estradiol.

Product ID45802-097_21863c5c-acca-485c-9517-41a9f16e7591
NDC45802-097
Product TypeHuman Prescription Drug
Proprietary NameEstradiol Vaginal
Generic NameEstradiol
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2021-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA210194
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameESTRADIOL
Active Ingredient Strength0 mg/g
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 45802-097-35

1 TUBE in 1 CARTON (45802-097-35) > 42.5 g in 1 TUBE
Marketing Start Date2021-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-097-35 [45802009735]

Estradiol Vaginal CREAM
Marketing CategoryANDA
Application NumberANDA210194
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-31
Marketing End Date2018-01-31

Drug Details

Medicade Reported Pricing

45802097426 CETIRIZINE HCL 1 MG/ML SOLN

Pricing Unit: ML | Drug Type:

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.