Koate
- Product NDC
- 76125-258
- 11-digit product format
- 761250258
- Labeler code
- 76125
- Product ID
- 76125-258_39b47b35-753a-47ca-aa93-3ec34e28b599
- 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 | 23 |
| 76125-258-02 | Koate | 1 in 1 CARTON | KIT | 1 | | 23 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Antihemophilic Factor Human | ACTIVE INGREDIENT | 839MOZ74GK | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Antihemophilic Factor Human | ACTIVE MOIETY | 839MOZ74GK | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Albumin (human) | INACTIVE INGREDIENT | ZIF514RVZR | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Aluminum | INACTIVE INGREDIENT | CPD4NFA903 | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Calcium Chloride | INACTIVE INGREDIENT | M4I0D6VV5M | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Glycine | INACTIVE INGREDIENT | TE7660XO1C | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
| Tri-n-butyl Phosphate | INACTIVE INGREDIENT | 95UAS8YAF5 | KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76125-258 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 23 | Current NDC, Legacy NDC, 3 package rows | 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.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 |
| 76125-258-02 | 76125025802 | 1 KIT in 1 CARTON (76125-258-02) * 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 |