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United States · US · US:68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba
Levonorgestrel 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 · 1
- ndc1168462637293 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A202791
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": {
"18c143b6-2f83-4dcb-b84a-855739212f25": {
"match": "brand_token",
"title": "LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
"spl_version": "1",
"published_date": "2026-04-06"
}
},
"productid": "68462-637_ed921f2c-7961-477a-bbac-2e666d32e3ba",
"productndc": "68462-637",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202791",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.02MG;0.09MG",
"product_no": "001",
"approval_date": "Apr 9, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHINYL ESTRADIOL; LEVONORGESTREL",
"shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
"shortage_status": "current",
"proprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "ANDA202791",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"start_marketing_date": "20150409",
"active_numerator_strength": "20; 90"
}Related drugs
Other records sharing ATC code G03CA.
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