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United States · US · US:51862-514_9d1ee9ee-0e36-4055-9b6e-2445bc713cab
Desogestrel and Ethinyl Estradiol
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 · 4
- ndc1151862514011 BLISTER PACK in 1 PACKET (51862-514-01) / 1 KIT in 1 BLISTER PACK
- ndc1151862514021 BLISTER PACK in 1 CARTON (51862-514-02) / 1 KIT in 1 BLISTER PACK
- ndc1151862514033 BLISTER PACK in 1 CARTON (51862-514-03) / 1 KIT in 1 BLISTER PACK
- ndc1151862514066 BLISTER PACK in 1 CARTON (51862-514-06) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A091234
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"9bb13b85-5d54-4689-b915-50b1da3a525b": {
"match": "brand_token",
"title": "DESOGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
"spl_version": "1",
"published_date": "2026-02-06"
}
},
"productid": "51862-514_9d1ee9ee-0e36-4055-9b6e-2445bc713cab",
"productndc": "51862-514",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091234",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.15MG;0.03MG",
"product_no": "001",
"approval_date": "Jul 12, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Desogestrel and Ethinyl Estradiol",
"active_ingred_unit": null,
"application_number": "ANDA091234",
"marketing_category": "ANDA",
"nonproprietary_name": "Desogestrel and Ethinyl Estradiol",
"start_marketing_date": "20201004",
"active_numerator_strength": null
}Access this data programmatically
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