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United States · US · US:59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c
ESTRADIOL VAGINAL INSERTS
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651439088 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR
- ndc11596514391818 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
CXY7B3Q98Z
ESTRADIOL HEMIHYDRATE
RxCUI 236859
Orange Book
A216550
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": "59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c",
"productndc": "59651-439",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216550",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MCG",
"product_no": "001",
"approval_date": "Aug 2, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL HEMIHYDRATE",
"proprietary_name": "ESTRADIOL VAGINAL INSERTS",
"active_ingred_unit": "ug/1",
"application_number": "ANDA216550",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20240802",
"active_numerator_strength": "10"
}Related drugs
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