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United States · US · US:68462-656_bc4774d0-9902-4678-af65-69d6a70d9983
Norethindrone Acetate and Ethinyl Estradiol
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168462656293 POUCH in 1 CARTON (68462-656-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
- ndc11684626569090 TABLET in 1 BOTTLE (68462-656-90)
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A203038
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": {
"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": "68462-656_bc4774d0-9902-4678-af65-69d6a70d9983",
"productndc": "68462-656",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203038",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.0025MG;0.5MG",
"product_no": "001",
"approval_date": "Apr 2, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.005MG;1MG",
"product_no": "002",
"approval_date": "Apr 2, 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": "Norethindrone Acetate and Ethinyl Estradiol",
"active_ingred_unit": "ug/1; mg/1",
"application_number": "ANDA203038",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
"start_marketing_date": "20150402",
"active_numerator_strength": "2.5; .5"
}Related drugs
Other records sharing ATC code G03CA.
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