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United States · US · US:68462-504_299fb286-ee60-4950-8315-d310c6ce29cd
Hailey 1.5/30
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462504813 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A209297
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": {
"84f6d573-3022-4982-aaa4-ac69393210a2": {
"match": "brand_token",
"title": "HAILEY FE 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "11",
"published_date": "2026-02-02"
}
},
"productid": "68462-504_299fb286-ee60-4950-8315-d310c6ce29cd",
"productndc": "68462-504",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209297",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;1.5MG",
"product_no": "001",
"approval_date": "Jun 5, 2018"
}
],
"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": "Hailey 1.5/30",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209297",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
"start_marketing_date": "20180605",
"active_numerator_strength": ".03; 1.5"
}Related drugs
Other records sharing ATC code G03CA.
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