NDC 61938-456

INFASURF

Calfactant

INFASURF is a Endotracheal Suspension in the Human Prescription Drug category. It is labeled and distributed by Ony Biotech Inc.. The primary component is Calfactant.

• Product ID: 61938-456_2b1fdc35-c991-47ac-bac5-c91a521648d7
• NDC: 61938-456
• Product Type: Human Prescription Drug
• Proprietary Name: INFASURF
• Generic Name: Calfactant
• Dosage Form: Suspension
• Route of Administration: ENDOTRACHEAL
• Marketing Start Date: 2011-07-21
• Marketing Category: BLA / NDA
• Application Number: BLA020521
• Labeler Name: ONY Biotech Inc.
• Substance Name: CALFACTANT
• Active Ingredient Strength: 36 mg/mL
• Pharm Classes: Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 61938-456-03

1 VIAL, GLASS in 1 CARTON (61938-456-03) > 3 mL in 1 VIAL, GLASS

• Marketing Start Date: 2011-07-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61938-456-06 [61938045606]

INFASURF SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020521
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-07-21

NDC 61938-456-03 [61938045603]

INFASURF SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020521
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-07-21

Drug Details

Active Ingredients

Ingredient	Strength
CALFACTANT	35.7 mg/mL

OpenFDA Data

• SPL SET ID: 315c128a-272d-4c57-bfbe-1a8b3402af08
• Manufacturer:
  • ONY Biotech Inc.
• UNII:
  • Q4K217VGA9
• RxNorm Concept Unique ID - RxCUI:
  • 994039
  • 259611

Pharmacological Class

• Alveolar Surface Tension Reduction [PE]
• Surfactant [EPC]
• Surfactant Activity [MoA]
• Alveolar Surface Tension Reduction [PE]
• Surfactant [EPC]
• Surfactant Activity [MoA]