What is NDC 61938-456?

61938-456 is the product NDC for Infasurf (calfactant), Calfactant 35.7 mg/mL suspension, listed with the FDA by ONY Biotech Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ONY Biotech Inc., NDC labeler code 61938. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Infasurf?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Infasurf NDC 61938-456 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61938-456Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61938-0456Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
61938-456-03	61938045603	1 VIAL, GLASS in 1 CARTON (61938-456-03) / 3 mL in 1 VIAL, GLASSMarketed from Dec 12, 2002
61938-456-06	61938045606	1 VIAL, GLASS in 1 CARTON (61938-456-06) / 6 mL in 1 VIAL, GLASSMarketed from Oct 18, 1999

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Infasurf
Generic name (nonproprietary): calfactant
Active ingredients: Calfactant — 35.7 mg/mL
Dosage form: Suspension
Route: Endotracheal
Labeler: ONY Biotech Inc.NDC labeler code 61938
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 020521
Marketing start: Oct 18, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Alveolar Surface Tension Reduction (Physiologic effect)Surfactant Activity (Mechanism)
Identifiers: Product ID 61938-456_49ede145-f336-f2b5-e063-6294a90aefceSPL ID 49ede145-f336-f2b5-e063-6294a90aefceSPL set ID 315c128a-272d-4c57-bfbe-1a8b3402af08RxCUI 259611, 994039UNII Q4K217VGA9UPC 0361938456063, 0361938456032
Pharmacologic class: Surfactant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N461938045603 followed by a unit qualifier and the quantity

Package 61938-0456-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 31, 2026.

Indications (excerpt from the label)

INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61938-456

What is NDC 61938-456?: 61938-456 is the product NDC for Infasurf (calfactant), Calfactant 35.7 mg/mL suspension, listed with the FDA by ONY Biotech Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Infasurf (Calfactant).
What is the active ingredient?: Calfactant.
Who is the labeler?: ONY Biotech Inc., NDC labeler code 61938. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Infasurf?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Infasurf (Calfactant) NDC 61938-456