NDC 16110-245

Seysara

Sarecycline Hydrochloride

Seysara is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Sarecycline Hydrochloride.

• Product ID: 16110-245_46501118-219b-42a7-ad24-65a4ad7f42db
• NDC: 16110-245
• Product Type: Human Prescription Drug
• Proprietary Name: Seysara
• Generic Name: Sarecycline Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-04
• Marketing Category: NDA / NDA
• Application Number: NDA209521
• Labeler Name: Almirall, LLC
• Substance Name: SARECYCLINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Tetracycline-class Drug [EPC],P-Glycoprotein Inhibitors [MoA],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 16110-245-30

30 TABLET, COATED in 1 BOTTLE (16110-245-30)

• Marketing Start Date: 2019-01-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-245-30 [16110024530]

Seysara TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA209521
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-04

Drug Details

Active Ingredients

Ingredient	Strength
SARECYCLINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: b200957c-3004-4988-be97-9fd619a83649
• Manufacturer:
  • Almirall, LLC
• UNII:
  • 36718856JR
• RxNorm Concept Unique ID - RxCUI:
  • 2059029
  • 2059033
  • 2059031
  • 2059037
  • 2059023
  • 2059035
• UPC Code:
  • 0316110246307
  • 0316110247304
  • 0316110245300

Pharmacological Class

• Tetracycline-class Drug [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Tetracyclines [CS]

NDC Crossover Matching brand name "Seysara" or generic name "Sarecycline Hydrochloride"

NDC	Brand Name	Generic Name
16110-245	Seysara	sarecycline hydrochloride
16110-246	Seysara	sarecycline hydrochloride
16110-247	Seysara	sarecycline hydrochloride