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United States · US · US:0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f
Nortrel
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105559009423 POUCH in 1 CARTON (0555-9009-42) / 1 BLISTER PACK in 1 POUCH (0555-9009-80) / 21 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A072693
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": {
"140c50d6-c931-423a-9aa0-526eae7ab93c": {
"match": "brand_token",
"title": "NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "16",
"published_date": "2026-01-28"
}
},
"productid": "0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f",
"productndc": "0555-9009",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072693",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;1MG",
"product_no": "001",
"approval_date": "Feb 28, 1992"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORETHINDRONE",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "Nortrel",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA072693",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
"start_marketing_date": "20010613",
"active_numerator_strength": ".035; 1"
}Related drugs
Other records sharing ATC code G03CA.
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