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United States · US · US:0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735
Amethyst
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803472241 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A079218
AB
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": {
"99073fe0-eac8-44dd-abe6-623fa67d9e79": {
"match": "brand_token",
"title": "AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-09-08"
}
},
"productid": "0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735",
"productndc": "0480-3472",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "079218",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.02MG;0.09MG",
"product_no": "001",
"approval_date": "Jun 6, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; LEVONORGESTREL",
"shortage_reason": "Ethinyl Estradiol; Etonogestrel Ring",
"shortage_status": "current",
"proprietary_name": "Amethyst",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "ANDA079218",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"start_marketing_date": "20230301",
"active_numerator_strength": "20; 90"
}Related drugs
Other records sharing ATC code G03CA.
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