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United States · US · US:0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2f
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103787274533 POUCH in 1 CARTON (0378-7274-53) / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A202770
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": "ORAL",
"spl_meta": {
"38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
"match": "brand_token",
"title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "7",
"published_date": "2026-03-27"
}
},
"productid": "0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2f",
"productndc": "0378-7274",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202770",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;1.5MG",
"product_no": "001",
"approval_date": "Feb 19, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA202770",
"marketing_category": "ANDA",
"nonproprietary_name": "norethindrone acetate and ethinyl estradiol",
"start_marketing_date": "20190925",
"active_numerator_strength": ".03; 1.5"
}Related drugs
Other records sharing ATC code G03CA.
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