seysara

Generic: sarecycline hydrochloride

Labeler: almirall, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name seysara
Generic Name sarecycline hydrochloride
Labeler almirall, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

sarecycline hydrochloride 100 mg/1

Manufacturer
Almirall, LLC

Identifiers & Regulatory

Product NDC 16110-246
Product ID 16110-246_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209521
Listing Expiration 2026-12-31
Marketing Start 2019-01-04

Pharmacologic Class

Classes
p-glycoprotein inhibitors [moa] tetracycline-class drug [epc] tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16110246
Hyphenated Format 16110-246

Supplemental Identifiers

RxCUI
2059023 2059029 2059031 2059033 2059035 2059037
UPC
0316110245300 0316110246307
UNII
36718856JR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name seysara (source: ndc)
Generic Name sarecycline hydrochloride (source: ndc)
Application Number NDA209521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (16110-246-30)
source: ndc

Packages (1)

16110-246-30 30 TABLET, COATED in 1 BOTTLE (16110-246-30)

Ingredients (1)

sarecycline hydrochloride (100 mg/1)

Linked Drug Pages (1)

Seysara ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4f9be4df-4e12-4f08-8e6f-cb07926ea5e6", "openfda": {"upc": ["0316110245300", "0316110246307"], "unii": ["36718856JR"], "rxcui": ["2059023", "2059029", "2059031", "2059033", "2059035", "2059037"], "spl_set_id": ["b200957c-3004-4988-be97-9fd619a83649"], "manufacturer_name": ["Almirall, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (16110-246-30)", "package_ndc": "16110-246-30", "marketing_start_date": "20190104"}], "brand_name": "Seysara", "product_id": "16110-246_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6", "dosage_form": "TABLET, COATED", "pharm_class": ["P-Glycoprotein Inhibitors [MoA]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "16110-246", "generic_name": "sarecycline hydrochloride", "labeler_name": "Almirall, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Seysara", "active_ingredients": [{"name": "SARECYCLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "NDA209521", "marketing_category": "NDA", "marketing_start_date": "20190104", "listing_expiration_date": "20261231"}