Vaccine · BLA
BioThrax (Anthrax vaccine adsorbed) NDC 64678-211
Bacillus anthracis strain v770-np1-r antigens 100 ug/mL · Injection, Suspension · Intramuscular, Subcutaneous · Emergent BioDefense Operations Lansing, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64678-211-01 | 6467802110164678021101 | 1 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 antigens — 100 ug/mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular, Subcutaneous
- Labeler
- Emergent BioDefense Operations Lansing, LLCNDC labeler code 64678
- 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.
- NDC on a medical claim
N464678021101followed by a unit qualifier and the quantityPackage 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.
About NDC 64678-211
- What is NDC 64678-211?
- 64678-211 is the product NDC for BioThrax (anthrax vaccine adsorbed), Bacillus anthracis strain v770-np1-r antigens 100 ug/mL injection, suspension, listed with the FDA by Emergent BioDefense Operations Lansing, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BioThrax (Anthrax Vaccine Adsorbed).
- What is the active ingredient?
- Bacillus anthracis strain v770-np1-r antigens.
- Who is the labeler?
- Emergent BioDefense Operations Lansing, LLC, NDC labeler code 64678. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BioThrax?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.