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United States · US · US:63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f
Estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629871311 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR
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": "63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156f",
"productndc": "63629-8713",
"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",
"active_ingred_unit": "mg/g",
"application_number": "ANDA209767",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20180305",
"active_numerator_strength": ".1"
}Related drugs
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