Koate
- Product NDC
- 76125-259
- 11-digit product format
- 761250259
- Labeler code
- 76125
- Product ID
- 76125-259_703c908c-e602-4a36-9b58-1ba7206d18ea
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ANTIHEMOPHILIC FACTOR (HUMAN)
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- KEDRION BIOPHARMA, INC.
- Application
- BLA101130
- Marketing category
- BLA
- Marketing start
- 1999-05-20
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Koate
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76125-252-21 | Koate | 5 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 250 [iU] in 5mL | 10 |
| 76125-259-02 | Koate | 1 in 1 CARTON | KIT | 1 | | 10 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76125-259 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 101130 | Koate, Koate-Dvi | Antihemophilic Factor (Human) | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76125-252-21 | 76125025221 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |
| 76125-259-02 | 76125025902 | 1 KIT in 1 CARTON (76125-259-02) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (76297-002-02) | 1 kit | 1999-05-20 | 0000-00-00 | No | No | Current |
| 76297-002-02 | 76297000202 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |