Curosurf (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

CUROSURF (poractant alfa) intratracheal suspension is a white to creamy white suspension available in sterile, rubber-stoppered clear glass vials containing (one vial per carton):

• 120 mg/1.5 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension: NDC Number: 10122-510-01
• 240 mg/3 mL (80 mg/mL) poractant alfa (surfactant extract) of suspension. NDC Number: 10122-510-03

Store CUROSURF intratracheal suspension in a refrigerator at +2°C to +8°C (36°F to 46°F). PROTECT FROM LIGHT. Do not shake. Vials are for single-dose only. After opening the vial discard the unused portion [see Dosage and Administration (2.3)].

Manufactured by:

Chiesi USA, Inc.

Cary, NC 27518

U.S.License No. 2150

Manufactured at and licensed from:

Chiesi Farmaceutici, S.p.A.

Parma, Italy 43100

CTC-007-0320-03-SPL-1

CUROSURF poractant alfa suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-510 Route of Administration ENDOTRACHEAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORACTANT ALFA (PORACTANT ALFA) PORACTANT ALFA 80 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10122-510-03 3.0 mL in 1 VIAL, GLASS None 2 NDC:10122-510-01 1.5 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA020744 11/18/1999

Labeler — Chiesi USA, Inc. (088084228)

Registrant — Chiesi USA, Inc. (088084228)

Revised: 05/2022 Chiesi USA, Inc.