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United States · US · US:51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c
Zovia 1/35
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1151862894011 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK
- ndc1151862894033 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A209548
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"d0d2a9e9-e9ce-4a42-b429-5c1f9a544795": {
"match": "brand_token",
"title": "ZOVIA 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS) KIT [MAYNE PHARMA INC.]",
"spl_version": "3",
"published_date": "2025-11-17"
}
},
"productid": "51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c",
"productndc": "51862-894",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "209548",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.035MG;1MG",
"product_no": "001",
"approval_date": "Feb 11, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Zovia 1/35",
"active_ingred_unit": null,
"application_number": "ANDA209548",
"marketing_category": "ANDA",
"nonproprietary_name": "Ethynodiol Diacetate and Ethinyl Estradiol Tablets",
"start_marketing_date": "20201016",
"active_numerator_strength": null
}Access this data programmatically
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