NDC codes

FDA NDC Directory
Product NDC (as listed)44206-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44206-0300Add 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
44206-300-01442060300011 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90)Marketed from Jan 6, 2009
44206-300-104420603001010 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90)Marketed from Jan 6, 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)
Rhophylac
Generic name (nonproprietary)
human rho(d) immune globulin
Active ingredients
Human rho(D) immune globulin — 1500 [iU]/2mL
Dosage form
Solution
Route
Intramuscular, Intravenous
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125070
Marketing start
Listing expires
Other FDA classes
Endogenous Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers
Product ID 44206-300_32c1f783-bd20-45bc-98d8-cdd5efa9f0d6SPL ID 32c1f783-bd20-45bc-98d8-cdd5efa9f0d6
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

N444206030001 followed by a unit qualifier and the quantity

Package 44206-0300-01. 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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