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United States · US · US:0430-3754_4d3bc996-2273-415e-9fc1-158037932e15
ESTRACE
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11043037541436 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR
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": "0430-3754_4d3bc996-2273-415e-9fc1-158037932e15",
"productndc": "0430-3754",
"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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