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

1.5 mL vial label
(click image for full-size original)

Curosurf 1.5mL carton
(click image for full-size original)

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.

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