🇺🇸
United States · US · US:68788-8626_b178ce8e-d12f-4a03-b69e-8d48a2ee2d66
Estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878886261100 TABLET in 1 BOTTLE (68788-8626-1)
- ndc11687888626330 TABLET in 1 BOTTLE (68788-8626-3)
- ndc11687888626660 TABLET in 1 BOTTLE (68788-8626-6)
- ndc11687888626990 TABLET in 1 BOTTLE (68788-8626-9)
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A217334
ABABAB
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": "ORAL",
"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": "68788-8626_b178ce8e-d12f-4a03-b69e-8d48a2ee2d66",
"productndc": "68788-8626",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217334",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Sep 6, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Sep 6, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Sep 6, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217334",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20240409",
"active_numerator_strength": ".5"
}Related drugs
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