NDC codes

FDA NDC Directory
Product NDC (as listed)44206-436Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44206-0436Add 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
44206-436-05442060436051 VIAL, GLASS in 1 CARTON (44206-436-05) / 50 mL in 1 VIAL, GLASS (44206-436-90)Marketed from Jan 20, 2009

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)
Privigen
Generic name (nonproprietary)
human immunoglobulin g
Active ingredients
Human immunoglobulin g — 5 g/50mL
Dosage form
Liquid
Route
Intravenous
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125201
Marketing start
Listing expires
Other FDA classes
Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers
Product ID 44206-436_f9f52f8d-e858-44ed-a529-5764c0d2f01eSPL ID f9f52f8d-e858-44ed-a529-5764c0d2f01e
Pharmacologic class
Human Immunoglobulin G

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

N444206043605 followed by a unit qualifier and the quantity

Package 44206-0436-05. 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.

Other NDCs under BLA 125201

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125201
ProductStrengthForm · routeLabelerProduct NDC
Privigenhuman immunoglobulin gHuman immunoglobulin g 20 g/200mLLiquidIntravenousCSL Behring AG44206-438
Privigenhuman immunoglobulin gHuman immunoglobulin g 10 g/100mLLiquidIntravenousCSL Behring AG44206-437
Privigenhuman immunoglobulin gHuman immunoglobulin g 40 g/400mLLiquidIntravenousCSL Behring AG44206-439

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