Plasma derivative · BLA
AlphaNine SD (Coagulation factor ix (human)) NDC 68516-3612
Kit · Intravenous · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68516-3612-2 | 68516361202 | 1 KIT in 1 CARTON (68516-3612-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)Marketed from Dec 31, 1990 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- AlphaNine SDSuffix: SD
- Generic name (nonproprietary)
- coagulation factor ix (human)
- Dosage form
- Kit
- Route
- Intravenous
- Labeler
- GRIFOLS USA, LLCNDC labeler code 68516
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103249
- Marketing start
- Listing expires
- Identifiers
- Product ID 68516-3612_8b01a6ae-2639-401f-9b03-45350a21e166SPL ID 8b01a6ae-2639-401f-9b03-45350a21e166
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.
- NDC on a medical claim
N468516361202followed by a unit qualifier and the quantityPackage 68516-3612-02. 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 68516-3612
- What is NDC 68516-3612?
- 68516-3612 is the product NDC for AlphaNine SD (coagulation factor ix (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?
- AlphaNine SD (Coagulation factor ix (Human)).
- Who is the labeler?
- GRIFOLS USA, LLC, NDC labeler code 68516. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AlphaNine SD?
- 5 other product NDCs are listed under this name. See all AlphaNine SD NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other AlphaNine SD products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3607 | 68516-3607-02 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3608 | 68516-3608-02 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3609 | 68516-3609-02 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3610 | 68516-3610-02 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3611 | 68516-3611-02 |
Other NDCs under BLA 103249
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 |
|---|---|---|---|---|
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3607 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3608 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3609 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3610 |
| AlphaNine SDcoagulation factor ix (human) | — | KitIntravenous | GRIFOLS USA, LLC | 68516-3611 |