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 | 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0169-7825-01 | EA - Each | 0169-7825 | 1975ebe2-5015-47c4-8847-ffd87a5e6a9b | 1 | 2015-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | ACTIVE INGREDIENT | P89DR4NY54 | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | ACTIVE MOIETY | P89DR4NY54 | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | NOVOEIGHT (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [NOVO NORDISK] | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1719246 | Novoeight 1 UNT Injection | PSN | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
| 1737559 | turoctocog alfa 1 UNT Injection | PSN | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
| 1719246 | turoctocog alfa 1 UNT Injection [Novoeight] | SBD | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
| 1737559 | turoctocog alfa 1 UNT Injection | SCD | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
| 1737559 | antihemophilic factor, human B-domain truncated recombinant 1 UNT Injection | SY | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
| 1719246 | Novoeight 1 UNT Injection | SY | 0a19a631-f494-48ac-8cab-7d572bf7b03d | 12 |
Packages#
| 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 |