What is NDC 0169-7903?

0169-7903 is the product NDC for Rebinyn kit, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.

Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rebinyn?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rebinyn NDC 0169-7903 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0169-7903Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00169-7903Add 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
0169-7903-01	0016979030100169790301	1 KIT in 1 KIT (0169-7903-01) * 4 mL in 1 VIAL, GLASS (0169-7933-11) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98)Marketed from Aug 11, 2022

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): Rebinyn
Generic name (nonproprietary): coagulation factor ix recombinant, glycopegylated
Dosage form: Kit
Labeler: Novo NordiskNDC labeler code 0169
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125611
Marketing start: Aug 11, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 0169-7903_4d658384-07d9-471f-8b15-16b8cec36765SPL ID 4d658384-07d9-471f-8b15-16b8cec36765SPL set ID 0ea37235-35fd-410d-b8c4-40ba15fe1294RxCUI 1990857, 1990862

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

N400169790301 followed by a unit qualifier and the quantity

Package 00169-7903-01. 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 Aug 11, 2022.

Indications (excerpt from the label)

REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX de…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0169-7903

What is NDC 0169-7903?: 0169-7903 is the product NDC for Rebinyn kit, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rebinyn (Coagulation factor IX recombinant, GlycoPEGylated).
Who is the labeler?: Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rebinyn?: 3 other product NDCs are listed under this name. See all Rebinyn 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 Rebinyn NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7901	00169-7901-0100169-7901-97
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7902	00169-7902-0100169-7902-97
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7905	00169-7905-0100169-7905-97

Other NDCs under BLA 125611

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

FDA NDC Directory listings under BLA 125611
Product	Strength	Form · route	Labeler	Product NDC
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7901
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7902
Rebinyncoagulation factor ix recombinant, glycopegylated	—	Kit	Novo Nordisk	0169-7905