What is NDC 0026-3946?

0026-3946 is the product NDC for Jivi kit, listed with the FDA by Bayer HealthCare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Jivi (Antihemophilic Factor (Recombinant) Pegylated-aucl).

Bayer HealthCare LLC, NDC labeler code 0026. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Jivi?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Jivi NDC 0026-3946 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0026-3946Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00026-3946Add 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
0026-3946-25	0002639462500026394625	1 KIT in 1 BOX (0026-3946-25) * 2.5 mL in 1 VIAL (0026-4946-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4946-01)Marketed from Aug 30, 2018
0026-3946-99	0002639469900026394699	1 KIT in 1 BOX (0026-3946-99) * 2.5 mL in 1 VIAL (0026-4946-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4946-01)Marketed from Aug 30, 2018

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): Jivi
Generic name (nonproprietary): antihemophilic factor (recombinant) pegylated-aucl
Dosage form: Kit
Labeler: Bayer HealthCare LLCNDC labeler code 0026
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125661
Marketing start: Aug 30, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 0026-3946_15230046-a8a7-4a1c-b279-ae307d278515SPL ID 15230046-a8a7-4a1c-b279-ae307d278515

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

N400026394625 followed by a unit qualifier and the quantity

Package 00026-3946-25. 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.

About NDC 0026-3946

What is NDC 0026-3946?: 0026-3946 is the product NDC for Jivi kit, listed with the FDA by Bayer HealthCare LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Jivi (Antihemophilic Factor (Recombinant) Pegylated-aucl).
Who is the labeler?: Bayer HealthCare LLC, NDC labeler code 0026. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Jivi?: 4 other product NDCs are listed under this name. See all Jivi NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Jivi NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3950	00026-3950-5000026-3950-99
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3942	00026-3942-2500026-3942-99
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3944	00026-3944-2500026-3944-99
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3948	00026-3948-2500026-3948-99

Other NDCs under BLA 125661

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

FDA NDC Directory listings under BLA 125661
Product	Strength	Form · route	Labeler	Product NDC
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3942
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3944
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3948
Jiviantihemophilic factor (recombinant) pegylated-aucl	—	Kit	Bayer HealthCare LLC	0026-3950