🇺🇸
United States · US · US:53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30
Estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1153746226218 APPLICATOR in 1 CARTON (53746-226-21) / 1 INSERT in 1 APPLICATOR
- ndc11537462262318 APPLICATOR in 1 CARTON (53746-226-23) / 1 INSERT in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A205256
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": "53746-226_eb2cbf77-ea3e-4604-9271-cd2228059e30",
"productndc": "53746-226",
"dosage_form": "INSERT",
"orange_book": {
"appl_no": "205256",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MCG",
"product_no": "001",
"approval_date": "May 29, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol",
"active_ingred_unit": "ug/1",
"application_number": "ANDA205256",
"marketing_category": "ANDA",
"nonproprietary_name": "Estradiol",
"start_marketing_date": "20150607",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G03CA03.
- GBAdgyn Estro 2mg tabletsKyowa Kirin Ltd
- GBAerodiol 150micrograms/dose nasal sprayServier Laboratories Ltd
- GBBedol 2mg tabletsReSource Medical UK Ltd
- NLCetura 0,5 mg tablettenACE Pharmaceuticals B.V.
- FIClimaraBayer Oy
- FIClimaraBayer Schering Pharma Oy
- 🇺🇸ClimaraBayer HealthCare Pharmaceuticals Inc.
- 🇺🇸ClimaraBayer HealthCare Pharmaceuticals Inc.
Access this data programmatically
Query Estradiol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.