Ibuprofen Lysine (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ibuprofen Lysine Injection is dispensed in clear plastic single-use vials, each containing 2 mL of sterile solution (NDC 39822-1030-1). The solution is not buffered and contains no preservatives. Each milliliter contains 17.1 mg/mL (±)-ibuprofen L-lysine [equivalent to 10 mg/mL (±)-ibuprofen] dissolved in Water for Injection, USP. Ibuprofen Lysine Injection is supplied in a carton containing 3 single-use vials (NDC 39822-1030-2).

Storage and Handling

Store at 20 to 25°C (68 to 77°F); excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store vials in carton until contents have been used.

17 PATIENT COUNSELING INFORMATION

Infection

Ibuprofen Lysine Injection may alter signs of infection. Patients’ caregivers should be informed that the infant will be carefully monitored for any signs of infection.

Platelet Aggregation

Patients’ caregivers should be informed that like other NSAIDS, Ibuprofen Lysine Injection can inhibit clot formation therefore their infant will be monitored for any signs of bleeding.

Administration

Patients’ caregivers should be informed that the infants’ skin and tissues will be monitored as leakage from administration may be irritating to tissue.

Manufactured for:

XGen Pharmaceuticals DJB, Inc.

Big Flats, NY 14814

IBUL-PI-08

PRINCIPAL DISPLAY PANEL

NDC 39822-1030-1
3 x 2 mL Single Use Vials
Ibuprofen Lysine Injection
10 mg/mL
Sterile Solution for IV Use Only

NDC 39822-1030-2

3 x 2 mL Single Use Vials
Ibuprofen Lysine Injection10 mg/mL

Each mL contains:
Ibuprofen 10 mg (as ibuprofen lysine) in Water for Injection, USP.
Dilute to an appropriate volume with dextrose or saline. Please refer to the Package Insert for full prescribing information.
Store at 20-25ºC (68-77ºF); excursions permitted 15-30ºC (59-86ºF). Store vials in carton until use.

IBUPROFEN LYSINE ibuprofen lysine solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39822-1030 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN LYSINE (IBUPROFEN) IBUPROFEN 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:39822-1030-2 3 VIAL in 1 CARTON contains a VIAL (39822-1030-1) 1 NDC:39822-1030-1 2 mL in 1 VIAL This package is contained within the CARTON (39822-1030-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202402 04/08/2016

Labeler — XGen Pharmaceuticals DJB, Inc. (117380305)

Revised: 01/2022 XGen Pharmaceuticals DJB, Inc.