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United States · US · US:50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87
ESTRACE
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090232101 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A086069
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": {
"dfc41fcd-c5ba-4b25-b647-cf04d3988b3e": {
"match": "brand_token",
"title": "ESTRACE (ESTRADIOL) CREAM [ALLERGAN, INC.]",
"spl_version": "25",
"published_date": "2024-11-05"
}
},
"productid": "50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87",
"productndc": "50090-2321",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "086069",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Jan 31, 1984"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "ESTRACE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA086069",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol",
"start_marketing_date": "20010701",
"active_numerator_strength": ".1"
}Related drugs
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