NDC codes

FDA NDC Directory
Product NDC (as listed)13533-318Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13533-0318Add 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
13533-318-01135330318011 VIAL in 1 CARTON (13533-318-01) / 1 mL in 1 VIAL (13533-318-10)Marketed from Jun 12, 1974
13533-318-03135330318031 VIAL in 1 CARTON (13533-318-03) / 3 mL in 1 VIAL (13533-318-30)Marketed from Jun 12, 1974
13533-318-05135330318051 VIAL in 1 CARTON (13533-318-05) / 5 mL in 1 VIAL (13533-318-50)Marketed from Jun 12, 1974

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)
HyperRAB
Generic name (nonproprietary)
rabies immune globulin (human)
Active ingredients
Human rabies virus immune globulin — 300 [iU]/mL
Dosage form
Injection, Solution
Route
Infiltration, Intramuscular
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 101144
Marketing start
Listing expires
Identifiers
Product ID 13533-318_880a0273-4487-4f86-a949-2c91898bdd78SPL ID 880a0273-4487-4f86-a949-2c91898bdd78

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

N413533031801 followed by a unit qualifier and the quantity

Package 13533-0318-01. 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.

Other NDCs under BLA 101144

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

FDA NDC Directory listings under BLA 101144
ProductStrengthForm · routeLabelerProduct NDC
Hyperrab S/Drabies immune globulin (human)Human rabies virus immune globulin 150 [iU]/mLInjectionIntramuscularGRIFOLS USA, LLC13533-618

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