🇺🇸
United States · US · US:0378-8770_e2eabf7d-64d8-4da1-84ea-450c03168e52
Estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103788770351 TUBE in 1 CARTON (0378-8770-35) / 42.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A208788
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": "0378-8770_e2eabf7d-64d8-4da1-84ea-450c03168e52",
"productndc": "0378-8770",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "208788",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Dec 29, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol",
"active_ingred_unit": "mg/g",
"application_number": "ANDA208788",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20171229",
"active_numerator_strength": ".1"
}Related drugs
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