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United States · US · US:75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502
Norethindrone Acetate and Ethinyl Estradiol
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1175834129293 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84)
- ndc11758341299090 TABLET in 1 BOTTLE (75834-129-90)
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A203435
ABAB
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": {
"38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
"match": "brand_token",
"title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "7",
"published_date": "2026-03-27"
}
},
"productid": "75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502",
"productndc": "75834-129",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203435",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.005MG;1MG",
"product_no": "001",
"approval_date": "Jun 3, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.0025MG;0.5MG",
"product_no": "002",
"approval_date": "Jun 3, 2016"
}
],
"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": "Norethindrone Acetate and Ethinyl Estradiol",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA203435",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
"start_marketing_date": "20161125",
"active_numerator_strength": ".0025; .5"
}Related drugs
Other records sharing ATC code G03CA.
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