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United States · US · US:59651-425_50c8c596-e201-4370-8487-421925c60b4e
Etyqa
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651425281 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1159651425871 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A214729
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": "ORAL",
"spl_meta": {
"afbc2a33-5eb2-4f01-91e9-07d8050da6ce": {
"match": "brand_token",
"title": "ETYQA (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]",
"spl_version": "2",
"published_date": "2024-03-08"
}
},
"productid": "59651-425_50c8c596-e201-4370-8487-421925c60b4e",
"productndc": "59651-425",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214729",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.5MG;0.1MG",
"product_no": "001",
"approval_date": "Jun 30, 2023"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1MG;0.5MG",
"product_no": "002",
"approval_date": "Jun 30, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
"proprietary_name": "Etyqa",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA214729",
"marketing_category": "ANDA",
"nonproprietary_name": "ESTRADIOL AND NORETHINDRONE ACETATE",
"start_marketing_date": "20230630",
"active_numerator_strength": ".5; .1"
}Related drugs
Other records sharing ATC code G03CA.
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