NDC codes

FDA NDC Directory
Product NDC (as listed)0169-7208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00169-7208Add 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 NDC11-digit (billing)PackageCopy
0169-7208-01001697208011 KIT in 1 KIT (0169-7208-01) * 8 mL in 1 SYRINGE, GLASS (0169-7018-98) * 8 mL in 1 VIAL, GLASS (0169-7218-11)Marketed from Oct 29, 2012

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)
NovoSeven RTSuffix: RT
Generic name (nonproprietary)
coagulation factor viia (recombinant)
Dosage form
Kit
Labeler
Novo NordiskNDC labeler code 0169
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 103665
Marketing start
Listing expires
Identifiers
Product ID 0169-7208_eeebef79-2f60-467f-b01f-58a34f0a8175SPL ID eeebef79-2f60-467f-b01f-58a34f0a8175

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

N400169720801 followed by a unit qualifier and the quantity

Package 00169-7208-01. 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

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

About NDC 0169-7208

What is NDC 0169-7208?
0169-7208 is the product NDC for NovoSeven RT (coagulation factor viia (recombinant)) 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?
NovoSeven RT (Coagulation Factor VIIa (Recombinant)).
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 NovoSeven RT?
7 other product NDCs are listed under this name. See all NovoSeven RT 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 NovoSeven RT NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-720100169-7201-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-720200169-7202-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-720500169-7205-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-704000169-7040-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-702000169-7020-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-705000169-7050-01
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-701000169-7010-01

Other NDCs under BLA 103665

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

FDA NDC Directory listings under BLA 103665
ProductStrengthForm · routeLabelerProduct NDC
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7205
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7010
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7020
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7040
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7050
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7201
NovoSeven RTcoagulation factor viia (recombinant)—KitNovo Nordisk0169-7202

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