NDC codes

FDA NDC Directory
Product NDC (as listed)0169-8200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00169-8200Add 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
0169-8200-01001698200011 KIT in 1 KIT (0169-8200-01) * 4 mL in 1 VIAL, GLASS (0169-8201-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)Marketed from Feb 19, 2019

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)
Esperoct
Generic name (nonproprietary)
antihemophilic factor (recombinant), glycopegylated-exei
Dosage form
Kit
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125671
Marketing start
Listing expires
Identifiers
Product ID 0169-8200_d47af230-b125-4bd9-b36c-51e8f90b22bcSPL ID d47af230-b125-4bd9-b36c-51e8f90b22bc

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

N400169820001 followed by a unit qualifier and the quantity

Package 00169-8200-01. 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.

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