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United States · US · US:51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fb
Azurette
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 · 3
- ndc1151862890011 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACK
- ndc1151862890021 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACK
- ndc1151862890033 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A091247
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"bff09a7b-aea6-460b-a263-44576e00f510": {
"match": "brand_token",
"title": "AZURETTE ( DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MAYNE PHARMA INC.]",
"spl_version": "3",
"published_date": "2025-09-10"
}
},
"productid": "51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fb",
"productndc": "51862-890",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091247",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.15MG,N/A;0.02MG,0.01MG",
"product_no": "001",
"approval_date": "Aug 1, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Azurette",
"active_ingred_unit": null,
"application_number": "ANDA091247",
"marketing_category": "ANDA",
"nonproprietary_name": "desogestrel/ethinyl estradiol and ethinyl estradiol",
"start_marketing_date": "20201003",
"active_numerator_strength": null
}Access this data programmatically
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