NDC codes

FDA NDC Directory
Product NDC (as listed)64208-7753Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64208-7753Add 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
64208-7753-1642087753011 KIT in 1 CARTON (64208-7753-1) * 10 mL in 1 VIAL, GLASS (64208-7756-1) * 5 mL in 1 VIAL, GLASS (64208-7755-2)Marketed from Oct 21, 2015

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Coagadex
Generic name (nonproprietary)
coagulation factor x human
Dosage form
Kit
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125506
Marketing start
Listing expires
Identifiers
Product ID 64208-7753_da6c9eef-d88e-4d24-96f4-87081ccf7dd0SPL ID da6c9eef-d88e-4d24-96f4-87081ccf7dd0SPL set ID ad20e6ff-98bc-47e6-aa00-7fb441edd2b0RxCUI 1719235, 1719240

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

N464208775301 followed by a unit qualifier and the quantity

Package 64208-7753-01. 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 .

Indications (excerpt from the label)

COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) On-demand treatment and control of bleeding episodes ( 1 ) Perioperat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125506

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

FDA NDC Directory listings under BLA 125506
ProductStrengthForm · routeLabelerProduct NDC
Coagadexcoagulation factor x human—KitBio Products Laboratory Ltd64208-7752

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