Plasma derivative · BLA
Koate (Antihemophilic factor (human)) NDC 76125-672
Kit · KEDRION BIOPHARMA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76125-672-50 | 7612506725076125067250 | 1 KIT in 1 CARTON (76125-672-50) * 10 mL in 1 VIAL, GLASS (13533-000-05) * 10 mL in 1 VIAL, GLASS (76125-673-51)Marketed from May 20, 1999 |
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)
- Koate
- Generic name (nonproprietary)
- antihemophilic factor (human)
- Dosage form
- Kit
- Labeler
- KEDRION BIOPHARMA, INC.NDC labeler code 76125
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101130
- Marketing start
- Listing expires
- Identifiers
- Product ID 76125-672_39b47b35-753a-47ca-aa93-3ec34e28b599SPL ID 39b47b35-753a-47ca-aa93-3ec34e28b599
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
N476125067250followed by a unit qualifier and the quantityPackage 76125-0672-50. 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 76125-672
- What is NDC 76125-672?
- 76125-672 is the product NDC for Koate (antihemophilic factor (human)) kit, listed with the FDA by KEDRION BIOPHARMA, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Koate (Antihemophilic Factor (Human)).
- Who is the labeler?
- KEDRION BIOPHARMA, INC., NDC labeler code 76125. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Koate?
- 17 other product NDCs are listed under this name. See all Koate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Koate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Koateantihemophilic factor (human) | — | Kit | KEDRION BIOPHARMA, INC. | 76125-250 | 76125-0250-20 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-253 | 76125-0253-25 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-256 | 76125-0256-20 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-257 | 76125-0257-25 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-258 | 76125-0258-02 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-259 | 76125-0259-02 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-661 | 76125-0661-02 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-662 | 76125-0662-50 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-663 | 76125-0663-50 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-665 | 76125-0665-02 |
Other NDCs under BLA 101130
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 |
|---|---|---|---|---|
| Koateantihemophilic factor (human) | — | Kit | KEDRION BIOPHARMA, INC. | 76125-250 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-253 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-256 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-257 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-258 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-259 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-661 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-662 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-663 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-665 |
| Koateantihemophilic factor (human) | — | Kit | KEDRION BIOPHARMA, INC. | 76125-667 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-668 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-674 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-675 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-676 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-678 |
| Koateantihemophilic factor (human) | — | KitIntravenous | KEDRION BIOPHARMA, INC. | 76125-679 |