NOVOEIGHT
- Product NDC
- 0169-7825
- 11-digit product format
- 001697825
- Labeler code
- 0169
- Product ID
- 0169-7825_590d35a4-6e12-450e-9508-0c5bbf2ac427
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- antihemophilic factor recombinant
- Dosage form
- KIT
- Labeler
- Novo Nordisk
- Application
- BLA125466
- Marketing category
- BLA
- Marketing start
- 2015-04-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NOVOEIGHT
- 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 |
|---|
| 0169-7825-01 | NOVOEIGHT | 1 in 1 KIT | KIT | 1 | | 12 |
| 0169-7829-11 | NOVOEIGHT | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 62.5 [iU] in 1mL | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-7825 | NOVOEIGHT (ANTIHEMOPHILIC FACTOR RECOMBINANT) KIT [NOVO NORDISK] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240524_0a19a631-f494-48ac-8cab-7d572bf7b03d.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125466 | Novoeight | Antihemophilic Factor (Recombinant) | 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 |
|---|
| 0169-7825-01 | 00169782501 | 1 KIT in 1 KIT (0169-7825-01) * 4 mL in 1 VIAL, GLASS (0169-7829-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) | 1 kit | 2015-04-01 | 0000-00-00 | No | No | Current |
| 0169-7829-11 | 00169782911 | 4 mL in 1 VIAL, GLASS | 4 ml | | | | | Historical |