🇺🇸
United States · US · US:21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13
ESTRADIOL VAGINAL
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1121922085061 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
CXY7B3Q98Z
ESTRADIOL HEMIHYDRATE
RxCUI 236859
Orange Book
A209767
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CXY7B3Q98Z",
"rxcui": "236859",
"inchikey": "ZVVGLAMWAQMPDR-WVEWYJOQSA-N",
"display_name": "ESTRADIOL HEMIHYDRATE",
"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": "21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13",
"productndc": "21922-085",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "209767",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Mar 5, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL HEMIHYDRATE",
"proprietary_name": "ESTRADIOL VAGINAL",
"active_ingred_unit": "mg/g",
"application_number": "ANDA209767",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20250814",
"active_numerator_strength": ".1"
}Related drugs
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