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United States · US · US:70710-1190_404277f1-4343-462c-b508-10c22dc7bc2c
norelgestromin and ethinyl estradiol
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170710119033 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCH
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A214594
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Ethinyl Diacetate Tablet
Raw payload (JSON)
{
"unii": {
"unii": "423D2T571U",
"rxcui": "4124",
"inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
"display_name": "ETHINYL ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TRANSDERMAL",
"spl_meta": {
"7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9": {
"match": "brand_token",
"title": "NORELGESTROMIN AND ETHINYL ESTRADIOL PATCH [ZYDUS LIFESCIENCES LIMITED]",
"spl_version": "2",
"published_date": "2026-04-17"
}
},
"productid": "70710-1190_404277f1-4343-462c-b508-10c22dc7bc2c",
"productndc": "70710-1190",
"dosage_form": "PATCH",
"orange_book": {
"appl_no": "214594",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG/24HR;0.15MG/24HR",
"product_no": "001",
"approval_date": "Sep 14, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORELGESTROMIN",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "norelgestromin and ethinyl estradiol",
"active_ingred_unit": "ug/mg; ug/mg",
"application_number": "ANDA214594",
"marketing_category": "ANDA",
"nonproprietary_name": "norelgestromin and ethinyl estradiol",
"start_marketing_date": "20231121",
"active_numerator_strength": "35; 150"
}Related drugs
Other records sharing ATC code G03CA.
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