NDC codes

FDA NDC Directory
Product NDC (as listed)71655-103Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71655-0103Add 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
71655-103-01716550103011 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USEMarketed from Dec 14, 2012

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)
Raxibacumab
Generic name (nonproprietary)
raxibacumab
Active ingredients
Raxibacumab — 50 mg/mL
Dosage form
Injection
Route
Intravenous
Labeler
Emergent BioDefense Operations LansingNDC labeler code 71655
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125349
Marketing start
Listing expires
Other FDA classes
Anthrax Protective Antigen-directed Antibody Interactions (Mechanism)
Identifiers
Product ID 71655-103_5b24ce09-93c6-115b-e063-6394a90aa9f2SPL ID 5b24ce09-93c6-115b-e063-6394a90aa9f2
Pharmacologic class
Anthrax Protective Antigen-directed Antibody

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

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N471655010301 followed by a unit qualifier and the quantity

Package 71655-0103-01. 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 71655-103

What is NDC 71655-103?
71655-103 is the product NDC for Raxibacumab, Raxibacumab 50 mg/mL injection, listed with the FDA by Emergent BioDefense Operations Lansing. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Raxibacumab.
What is the active ingredient?
Raxibacumab.
Who is the labeler?
Emergent BioDefense Operations Lansing, NDC labeler code 71655. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Raxibacumab?
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.

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