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United States · US · US:16110-247_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6
Seysara
Orange BookUNIISPLATC J01AA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmirall, LLC
CountryUS (United States)
ATC codeJ01AA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11161102473030 TABLET, COATED in 1 BOTTLE (16110-247-30)
Annotations
UNII (FDA Substance ID)
36718856JR
SARECYCLINE HYDROCHLORIDE
RxCUI 2059038
Orange Book
N209521
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "36718856JR",
"rxcui": "2059038",
"inchikey": "APPRLAGZQKOUFL-FIPJBXKNSA-N",
"display_name": "SARECYCLINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b200957c-3004-4988-be97-9fd619a83649": {
"match": "brand_token",
"title": "SEYSARA (SARECYCLINE HYDROCHLORIDE) TABLET, COATED [ALMIRALL, LLC]",
"spl_version": "12",
"published_date": "2024-06-19"
}
},
"productid": "16110-247_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6",
"productndc": "16110-247",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "209521",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "001",
"approval_date": "Oct 1, 2018"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Oct 1, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "003",
"approval_date": "Oct 1, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SARECYCLINE HYDROCHLORIDE",
"proprietary_name": "Seysara",
"active_ingred_unit": "mg/1",
"application_number": "NDA209521",
"marketing_category": "NDA",
"nonproprietary_name": "sarecycline hydrochloride",
"start_marketing_date": "20190104",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code J01AA14.
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