Alphanate
- Product NDC
- 68516-4618
- 11-digit product format
- 685164618
- Labeler code
- 68516
- Product ID
- 68516-4618_62efdce0-9d8e-47ee-954c-9a4cbdfb525d
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor/von Willebrand Factor Complex (Human)
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA102475
- Marketing category
- BLA
- Marketing start
- 1978-08-15
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alphanate
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68516-4607-2 | Alphanate | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1000 [iU] in 10mL | 26 |
| 68516-4618-2 | Alphanate | 1 in 1 CARTON | KIT | 1 | | 26 |
| 76297-002-12 | Alphanate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 26 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68516-4618 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Current NDC, Legacy NDC, 3 package rows | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 102475 | Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | 351(a) | Rx | 2026-09-01 |
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 |
|---|
| 68516-4607-2 | 68516460702 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 68516-4618-2 | 68516461802 | 1 KIT in 1 CARTON (68516-4618-2) * 10 mL in 1 VIAL (68516-4607-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) | 1 kit | 1978-08-15 | 0000-00-00 | No | No | Current |
| 76297-002-12 | 76297000212 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | | Historical |