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United States · US · US:50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318
VIORELE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090139501 KIT in 1 KIT (50090-1395-0)
Annotations
Orange Book
A091346
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"39988aa6-8f68-40e8-9bdd-c40a3bdaad61": {
"match": "brand_token",
"title": "VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "17",
"published_date": "2026-02-02"
}
},
"productid": "50090-1395_fb1ff52e-d5ff-4ef2-9d1e-7dab6b047318",
"productndc": "50090-1395",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "091346",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.15MG,N/A;0.02MG,0.01MG",
"product_no": "001",
"approval_date": "Apr 2, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "VIORELE",
"active_ingred_unit": null,
"application_number": "ANDA091346",
"marketing_category": "ANDA",
"nonproprietary_name": "Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol",
"start_marketing_date": "20120404",
"active_numerator_strength": null
}Access this data programmatically
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