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United States · US · US:0781-4103_6471e7a9-16b1-4b84-a113-fe6ac0ca5640
Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107814103153 BLISTER PACK in 1 PACKAGE (0781-4103-15) / 1 KIT in 1 BLISTER PACK (0781-4103-52)
Annotations
Orange Book
N022574
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"6928f186-190d-4c40-beab-81cf80cd45cb": {
"match": "brand_token",
"title": "DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]",
"spl_version": "17",
"published_date": "2026-03-05"
}
},
"productid": "0781-4103_6471e7a9-16b1-4b84-a113-fe6ac0ca5640",
"productndc": "0781-4103",
"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": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium",
"active_ingred_unit": null,
"application_number": "NDA022574",
"marketing_category": "NDA",
"nonproprietary_name": "Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium",
"start_marketing_date": "20150801",
"active_numerator_strength": null
}Access this data programmatically
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