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United States · US · US:68462-318_985b7e31-558c-4e49-b6ff-a0951bc4a947
VIORELE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462318293 BLISTER PACK in 1 CARTON (68462-318-29) / 1 KIT in 1 BLISTER PACK (68462-318-84)
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": "68462-318_985b7e31-558c-4e49-b6ff-a0951bc4a947",
"productndc": "68462-318",
"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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