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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q4K217VGA9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259611Internal RxNorm lookup
994039Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
315c128a-272d-4c57-bfbe-1a8b3402af08Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFASURFCALFACTANTONY Biotech Inc.315c128a-272d-4c57-bfbe-1a8b3402af082026-03-31Warnings, Adverse reactionsExact identifier
application number: BLA020521
ndc (product): 61938-456

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020521Infasurfcalfactant351(a)Rx2026-08-01

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