🇺🇸
United States · US · US:63629-8804_b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020
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
- ndc11636298804118 BLISTER PACK in 1 CARTON (63629-8804-1) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A206388
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": "63629-8804_b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020",
"productndc": "63629-8804",
"dosage_form": "INSERT",
"orange_book": {
"appl_no": "206388",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MCG",
"product_no": "001",
"approval_date": "Jul 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol",
"active_ingred_unit": "ug/1",
"application_number": "ANDA206388",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20170724",
"active_numerator_strength": "10"
}Related drugs
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