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United States · US · US:68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7
Ashlyna
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
- ndc1168462646932 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91)
Annotations
Orange Book
A203163
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"407a9f63-9abf-4886-864a-d3dd0e429762": {
"match": "brand_token",
"title": "ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "10",
"published_date": "2026-01-30"
}
},
"productid": "68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7",
"productndc": "68462-646",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "203163",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG,0.01MG;0.15MG,N/A",
"product_no": "001",
"approval_date": "Feb 23, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Ashlyna",
"active_ingred_unit": null,
"application_number": "ANDA203163",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol",
"start_marketing_date": "20150223",
"active_numerator_strength": null
}Access this data programmatically
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