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United States · US · US:75907-091_f64171dd-ac43-4be5-ba1d-51cbcff7991e
Azurette
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy�s Laboratories Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1175907091281 BLISTER PACK in 1 PACKET (75907-091-28) / 1 KIT in 1 BLISTER PACK
- ndc1175907091626 BLISTER PACK in 1 CARTON (75907-091-62) / 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": "75907-091_f64171dd-ac43-4be5-ba1d-51cbcff7991e",
"productndc": "75907-091",
"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": "20240625",
"active_numerator_strength": null
}Access this data programmatically
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