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United States · US · US:50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9
Safyral
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11504194030090 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK
- ndc1150419403033 BLISTER PACK in 1 PACKAGE (50419-403-03) / 1 KIT in 1 BLISTER PACK (50419-403-01)
- ndc11504194037090 BLISTER PACK in 1 PACKAGE (50419-403-70) / 1 KIT in 1 BLISTER PACK
- ndc11504194037512 PACKAGE in 1 CARTON (50419-403-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71)
Annotations
Orange Book
N022574
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"97563516-306a-4e17-9690-edbda49ecd83": {
"match": "brand_token",
"title": "SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "23",
"published_date": "2026-03-05"
}
},
"productid": "50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9",
"productndc": "50419-403",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "022574",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "3MG,N/A;0.03MG,N/A;0.451MG,0.451MG",
"product_no": "001",
"approval_date": "Dec 16, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Safyral",
"active_ingred_unit": null,
"application_number": "NDA022574",
"marketing_category": "NDA",
"nonproprietary_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium",
"start_marketing_date": "20120213",
"active_numerator_strength": null
}Access this data programmatically
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