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United States · US · US:70700-312_4fb6f740-69bf-590d-4474-43ff5c2e5986
Rosyrah
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXiromed, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170700312871 POUCH in 1 CARTON (70700-312-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
A206053
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"d2f0af55-205f-df9c-c572-1f7b14976655": {
"match": "brand_token",
"title": "ROSYRAH (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [XIROMED, LLC]",
"spl_version": "2",
"published_date": "2026-01-08"
}
},
"productid": "70700-312_4fb6f740-69bf-590d-4474-43ff5c2e5986",
"productndc": "70700-312",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "206053",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A",
"product_no": "001",
"approval_date": "Oct 2, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Rosyrah",
"active_ingred_unit": null,
"application_number": "ANDA206053",
"marketing_category": "ANDA",
"nonproprietary_name": "levonorgestrel and ethinyl estradiol and ethinyl estradiol",
"start_marketing_date": "20250129",
"active_numerator_strength": null
}Access this data programmatically
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