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United States · US · US:68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4
estradiol
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168382323044 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A204379
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": "TRANSDERMAL",
"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": "68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4",
"productndc": "68382-323",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "204379",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.014MG/24HR",
"product_no": "001",
"approval_date": "Apr 17, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "estradiol",
"active_ingred_unit": "mg/d",
"application_number": "ANDA204379",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol",
"start_marketing_date": "20231102",
"active_numerator_strength": ".014"
}Related drugs
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