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United States · US · US:68180-828_42e98704-dee2-481c-849b-e3d9439a7005
Fyavolv
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11681808280990 TABLET, FILM COATED in 1 BOTTLE (68180-828-09)
- ndc1168180828733 POUCH in 1 CARTON (68180-828-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A204213
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Etonogestrel Ring
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": {
"772c86d7-10a4-48c5-8c19-f8aac68f5ab4": {
"match": "brand_token",
"title": "FYAVOLV (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]",
"spl_version": "18",
"published_date": "2026-01-13"
}
},
"productid": "68180-828_42e98704-dee2-481c-849b-e3d9439a7005",
"productndc": "68180-828",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204213",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.0025MG;0.5MG",
"product_no": "001",
"approval_date": "Dec 10, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.005MG;1MG",
"product_no": "002",
"approval_date": "Dec 10, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
"shortage_reason": "Ethinyl Estradiol; Etonogestrel Ring",
"shortage_status": "current",
"proprietary_name": "Fyavolv",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA204213",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
"start_marketing_date": "20160315",
"active_numerator_strength": ".005; 1"
}Related drugs
Other records sharing ATC code G03CA.
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