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United States · US · US:50102-233_8f45527d-e6cf-4eda-ac01-29618a778122
Tri-VyLibra
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAfaxys Pharma, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150102233111 BLISTER PACK in 1 CARTON (50102-233-11) / 1 KIT in 1 BLISTER PACK
- ndc1150102233133 BLISTER PACK in 1 CARTON (50102-233-13) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A205441
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"f59acc3e-21d9-4fa3-ad52-d77225739e1a": {
"match": "brand_token",
"title": "TRI-VYLIBRA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AFAXYS PHARMA, LLC]",
"spl_version": "10",
"published_date": "2024-02-16"
}
},
"productid": "50102-233_8f45527d-e6cf-4eda-ac01-29618a778122",
"productndc": "50102-233",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "205441",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
"product_no": "001",
"approval_date": "Jul 6, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Tri-VyLibra",
"active_ingred_unit": null,
"application_number": "ANDA205441",
"marketing_category": "ANDA",
"nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
"start_marketing_date": "20160706",
"active_numerator_strength": null
}Access this data programmatically
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