Plasma derivative · BLA
Prolastin-C (Alpha-1-proteinase inhibitor (human)) NDC 13533-703
Kit · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-703-10 | 1353307031013533070310 | 1 KIT in 1 CARTON (13533-703-10) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-200-20)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
- Generic name (nonproprietary)
- alpha-1-proteinase inhibitor (human)
- Dosage form
- Kit
- Labeler
- GRIFOLS USA, LLCNDC labeler code 13533
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103174
- Marketing start
- Listing expires
- Identifiers
- Product ID 13533-703_6a2d2b1f-c8f1-4002-ba1e-925179974d95SPL ID 6a2d2b1f-c8f1-4002-ba1e-925179974d95
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.
- NDC on a medical claim
N413533070310followed by a unit qualifier and the quantityPackage 13533-0703-10. 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 13533-703
- What is NDC 13533-703?
- 13533-703 is the product NDC for Prolastin-C (alpha-1-proteinase inhibitor (human)) kit, listed with the FDA by GRIFOLS USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prolastin-C (Alpha-1-proteinase inhibitor (Human)).
- Who is the labeler?
- GRIFOLS USA, LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prolastin-C?
- 2 other product NDCs are listed under this name. See all Prolastin-C NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prolastin-C products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prolastin-Calpha-1-proteinase inhibitor (human) | — | Kit | GRIFOLS USA, LLC | 13533-700 | 13533-0700-02 |
| Prolastin-Calpha-1-proteinase inhibitor (human) | — | Kit | GRIFOLS USA, LLC | 13533-706 | 13533-0706-22 |
Other NDCs under BLA 103174
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | 13533-706 |
| Prolastin-C Liquidalpha1-proteinase inhibitor (human) | .alpha.1-proteinase inhibitor human 1000 mg/20mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 13533-705 |