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United States · US · US:50742-659_514dd27c-d315-4775-91d2-a58ac2293edc
Dolishale
In shortageOrange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150742659281 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK
- ndc1150742659686 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK
- ndc1150742659843 BLISTER PACK in 1 CARTON (50742-659-84) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A091692
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": {
"036a15be-8c2e-4f65-b5dc-f333e2994d4a": {
"match": "brand_token",
"title": "DOLISHALE (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [INGENUS PHARMACEUTICALS, LLC]",
"spl_version": "2",
"published_date": "2025-04-09"
}
},
"productid": "50742-659_514dd27c-d315-4775-91d2-a58ac2293edc",
"productndc": "50742-659",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091692",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.02MG;0.09MG",
"product_no": "001",
"approval_date": "Oct 22, 2020"
}
],
"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": "Dolishale",
"active_ingred_unit": "ug/1; ug/1",
"application_number": "ANDA091692",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"start_marketing_date": "20210103",
"active_numerator_strength": "20; 90"
}Related drugs
Other records sharing ATC code G03CA.
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