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United States · US · US:51285-127_21f0dbf2-f0a8-447a-a975-482b4194b1eb
Loestrin
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Women's Health LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151285127975 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A076381
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": {
"f29ebcb5-7e65-4092-bfaa-f5ec026fc255": {
"match": "brand_token",
"title": "LOESTRIN 21 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET LOESTRIN FE 28 DAY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [TEVA WOMEN'S HEALTH LLC]",
"spl_version": "12",
"published_date": "2025-04-16"
}
},
"productid": "51285-127_21f0dbf2-f0a8-447a-a975-482b4194b1eb",
"productndc": "51285-127",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076381",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG;1.5MG",
"product_no": "001",
"approval_date": "May 30, 2003"
}
],
"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": "Loestrin",
"active_ingred_unit": "ug/1; mg/1",
"application_number": "ANDA076381",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
"start_marketing_date": "20150226",
"active_numerator_strength": "30; 1.5"
}Related drugs
Other records sharing ATC code G03CA.
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