🇺🇸
United States · US · US:45802-097_e656010f-9ad1-4a86-89c7-2315c4b0ec44
Estradiol Vaginal
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145802097351 TUBE in 1 CARTON (45802-097-35) / 42.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A210194
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4TI98Z838E",
"rxcui": "4083",
"inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
"display_name": "ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "VAGINAL",
"spl_meta": {
"50c786d6-91bd-4eea-9455-ff2abc08372f": {
"match": "brand_token",
"title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "45802-097_e656010f-9ad1-4a86-89c7-2315c4b0ec44",
"productndc": "45802-097",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "210194",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Jan 22, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol Vaginal",
"active_ingred_unit": "mg/g",
"application_number": "ANDA210194",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20210106",
"active_numerator_strength": ".1"
}Related drugs
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