Kovaltry NDC 0026-3821

NDC codes

FDA NDC Directory

Product NDC (as listed)0026-3821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00026-3821Add 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
0026-3821-25	00026382125	1 KIT in 1 BOX (0026-3821-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)Marketed from Mar 17, 2016
0026-3821-99	00026382199	1 KIT in 1 BOX (0026-3821-99) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)Marketed from Mar 17, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Kovaltry
Generic name (nonproprietary): antihemophilic factor (recombinant)
Dosage form: Kit
Labeler: Bayer HealthCare LLC
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125574
Marketing start: Mar 17, 2016
Listing expires: Dec 31, 2027
Identifiers: Product ID 0026-3821_f4bed724-db3e-448e-8947-2f6a6913f1eeSPL ID f4bed724-db3e-448e-8947-2f6a6913f1ee

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

N400026382125 followed by a unit qualifier and the quantity

Package 00026-3821-25. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 125574

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125574
Product	Strength	Form · route	Labeler	Product NDC
Kovaltryantihemophilic factor (recombinant)	—	Kit	Bayer HealthCare LLC	0026-3826
Kovaltryantihemophilic factor (recombinant)	—	Kit	Bayer HealthCare LLC	0026-3822
Kovaltryantihemophilic factor (recombinant)	—	Kit	Bayer HealthCare LLC	0026-3828
Kovaltryantihemophilic factor (recombinant)	—	Kit	Bayer HealthCare LLC	0026-3824

Kovaltry (antihemophilic factor (recombinant)) NDC 0026-3821