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United States · US · US:0555-9123_aaf5797d-3069-42ba-a8d2-088e5cd33b2c
Jolessa
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105559123663 POUCH in 1 CARTON (0555-9123-66) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
N021544
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"f1076019-6f2c-4c90-9f3c-ab0c7cdd9315": {
"match": "brand_token",
"title": "JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
"spl_version": "18",
"published_date": "2024-10-28"
}
},
"productid": "0555-9123_aaf5797d-3069-42ba-a8d2-088e5cd33b2c",
"productndc": "0555-9123",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "021544",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.03MG;0.15MG",
"product_no": "001",
"approval_date": "Sep 5, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Jolessa",
"active_ingred_unit": null,
"application_number": "NDA021544",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Levonorgestrel / Ethinyl Estradiol",
"start_marketing_date": "20031013",
"active_numerator_strength": null
}Access this data programmatically
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