FDA.reportPublic FDA data

INFASURF

Product NDC
61938-456
11-digit product format
619380456
Labeler code
61938
Product ID
61938-456_49ede145-f336-f2b5-e063-6294a90aefce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calfactant
Dosage form
SUSPENSION
Route
ENDOTRACHEAL
Labeler
ONY Biotech Inc.
Application
BLA020521
Marketing category
BLA
Marketing start
1999-10-18
Substance
CALFACTANT
Active strength
35.7 mg/mL
Pharmacologic classes
Alveolar Surface Tension Reduction [PE], Surfactant Activity [MoA], Surfactant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INFASURF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALFACTANT35.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ4K217VGA9
Rxcui259611, 994039

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61938-456-03INFASURF3 mL in 1 VIAL, GLASSSUSPENSION314
61938-456-03INFASURF1 in 1 CARTONSUSPENSION114
61938-456-06INFASURF6 mL in 1 VIAL, GLASSSUSPENSION614
61938-456-06INFASURF1 in 1 CARTONSUSPENSION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61938-456-03ML - Milliliter61938-456fc3e93d6-8ed1-41be-8aae-1b769ecb85e812012-07-24
61938-456-06ML - Milliliter61938-456e78e305c-6bad-46e6-b18b-1a113172ad2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALFACTANTACTIVE INGREDIENTQ4K217VGA9INFASURF (CALFACTANT) SUSPENSION [ONY, INC.]1
CALFACTANTACTIVE MOIETYQ4K217VGA9INFASURF (CALFACTANT) SUSPENSION [ONY, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XINFASURF (CALFACTANT) SUSPENSION [ONY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61938-456INFASURF (CALFACTANT) SUSPENSION [ONY BIOTECH INC.]13Current NDC, Legacy NDC, 4 package rows20250109_315c128a-272d-4c57-bfbe-1a8b3402af08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259611calfactant 35 MG/ML Intratracheal SuspensionPSN315c128a-272d-4c57-bfbe-1a8b3402af0814
994039INFASURF 35 MG/mL Intratracheal SuspensionPSN315c128a-272d-4c57-bfbe-1a8b3402af0814
994039calfactant 35 MG/ML Intratracheal Suspension [Infasurf]SBD315c128a-272d-4c57-bfbe-1a8b3402af0814
259611calfactant 35 MG/ML Intratracheal SuspensionSCD315c128a-272d-4c57-bfbe-1a8b3402af0814
994039Infasurf 35 MG/ML Intratracheal SuspensionSY315c128a-272d-4c57-bfbe-1a8b3402af0814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61938-456-03619380456031 VIAL, GLASS in 1 CARTON (61938-456-03) / 3 mL in 1 VIAL, GLASS2002-12-120000-00-00NoNoCurrent
61938-456-06619380456061 VIAL, GLASS in 1 CARTON (61938-456-06) / 6 mL in 1 VIAL, GLASS1999-10-180000-00-00NoNoCurrent