NDC codes

FDA NDC Directory
Product NDC (as listed)69604-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69604-0204Add 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
69604-204-02696040204021 VIAL, SINGLE-USE in 1 CARTON (69604-204-02) / 6 mL in 1 VIAL, SINGLE-USEMarketed from Mar 18, 2016

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)
Anthim
Generic name (nonproprietary)
obiltoxaximab
Active ingredients
Obiltoxaximab — 100 mg/mL
Dosage form
Solution
Route
Intravenous
Labeler
Elusys Therapeutics, Inc.NDC labeler code 69604
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125509
Marketing start
Listing expires
Other FDA classes
Anthrax Protective Antigen-directed Antibody Interactions (Mechanism)
Identifiers
Product ID 69604-204_767f2541-7d93-49c4-9078-bbecd9a9725fSPL ID 767f2541-7d93-49c4-9078-bbecd9a9725f
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

N469604020402 followed by a unit qualifier and the quantity

Package 69604-0204-02. 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 69604-204

What is NDC 69604-204?
69604-204 is the product NDC for Anthim (obiltoxaximab), Obiltoxaximab 100 mg/mL solution, listed with the FDA by Elusys Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Anthim (Obiltoxaximab).
What is the active ingredient?
Obiltoxaximab.
Who is the labeler?
Elusys Therapeutics, Inc., NDC labeler code 69604. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Anthim?
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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