Prolastin-C Liquid NDC 13533-705

NDC codes

FDA NDC Directory

Product NDC (as listed)13533-705Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13533-0705Add 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 NDC	11-digit (billing)	Package
13533-705-01	13533070501	1 VIAL in 1 CARTON (13533-705-01) / 20 mL in 1 VIAL (13533-705-11)Marketed from Dec 2, 1987
13533-705-31	13533070531	1 VIAL in 1 CARTON (13533-705-31) / 10 mL in 1 VIAL (13533-705-32)Marketed from Dec 2, 1987
13533-705-51	13533070551	1 VIAL in 1 CARTON (13533-705-51) / 80 mL in 1 VIAL (13533-705-52)Marketed from Dec 2, 1987

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): Prolastin-C Liquid
Generic name (nonproprietary): alpha1-proteinase inhibitor (human)
Active ingredients: .alpha.1-proteinase inhibitor human — 1000 mg/20mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: GRIFOLS USA, LLC
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103174
Marketing start: Dec 2, 1987
Listing expires: Dec 31, 2026
Other FDA classes: Trypsin Inhibitors (Mechanism)
Identifiers: Product ID 13533-705_f3f69bd6-df32-45c4-bbd9-b18b0d725382SPL ID f3f69bd6-df32-45c4-bbd9-b18b0d725382
Pharmacologic class: Human alpha-1 Proteinase Inhibitor

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

N413533070501 followed by a unit qualifier and the quantity

Package 13533-0705-01. 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 103174

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

FDA NDC Directory listings under BLA 103174
Product	Strength	Form · route	Labeler	Product NDC
Prolastin-Calpha-1-proteinase inhibitor (human)	—	Kit	GRIFOLS USA, LLC	13533-700
Prolastin-Calpha-1-proteinase inhibitor (human)	—	Kit	GRIFOLS USA, LLC	13533-703
Prolastin-Calpha-1-proteinase inhibitor (human)	—	Kit	GRIFOLS USA, LLC	13533-706

Prolastin-C Liquid (alpha1-proteinase inhibitor (human)) NDC 13533-705