ZEPBOUND Solution for injection Ref.[109319] Active ingredients: Tirzepatide

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains 2 non-coded amino acids (aminoisobutyric acid, Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68.

Structural formula:

ZEPBOUND is a clear, colorless to slightly yellow, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5-7.5.

Dosage Forms and Strengths

Injection: Clear, colorless to slightly yellow solution available in pre-filled single-dose pens of the following strengths:

  • 2.5 mg/0.5 mL
  • 5 mg/0.5 mL
  • 7.5 mg/0.5 mL
  • 10 mg/0.5 mL
  • 12.5 mg/0.5 mL
  • 15 mg/0.5 mL
How Supplied

ZEPBOUND is a clear, colorless to slightly yellow solution available in pre-filled single-dose pens as follows:

Total Strength per Total Volume Carton Contents NDC
2.5 mg/0.5 mL 4 single-dose pens 0002-2506-80
5 mg/0.5 mL 4 single-dose pens 0002-2495-80
7.5 mg/0.5 mL 4 single-dose pens 0002-2484-80
10 mg/0.5 mL 4 single-dose pens 0002-2471-80
12.5 mg/0.5 mL 4 single-dose pens 0002-2460-80
15 mg/0.5 mL 4 single-dose pens 0002-2457-80

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Drugs

Drug Countries
ZEPBOUND United States
 
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