NDC codes

FDA NDC Directory
Product NDC (as listed)64678-211Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64678-0211Add 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
64678-211-01646780211011 VIAL, MULTI-DOSE in 1 CARTON (64678-211-01) / 5 mL in 1 VIAL, MULTI-DOSE (64678-211-05)Marketed from Nov 4, 1970

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
BioThrax
Generic name (nonproprietary)
anthrax vaccine adsorbed
Active ingredients
Bacillus anthracis strain v770-np1-r antigens100 ug/mL
Dosage form
Injection, Suspension
Route
Intramuscular, Subcutaneous
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 103821
Marketing start
Listing expires
Other FDA classes
Actively Acquired Immunity (Physiologic effect)Anthrax Vaccines (Chemical/Ingredient)Attenuated (Chemical/Ingredient)
Identifiers
Product ID 64678-211_548ed5a0-4263-4c30-997d-24db0c078ddfSPL ID 548ed5a0-4263-4c30-997d-24db0c078ddf
Pharmacologic class
Live Attenuated Bacillus Anthracis Vaccine

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.

Administration

Immunization administration (CPT 90460–90474)

Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.

How CPT relates to drug billing

NDC on a medical claim

N464678021101 followed by a unit qualifier and the quantity

Package 64678-0211-01. 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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