🇺🇸
United States · US · US:66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6
Estradiol Vaginal Cream
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1166993002101 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A212313
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": "66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6",
"productndc": "66993-002",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "212313",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.01%",
"product_no": "001",
"approval_date": "Jul 15, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "Estradiol Vaginal Cream",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212313",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol",
"start_marketing_date": "20211001",
"active_numerator_strength": ".1"
}Related drugs
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