ALPROLIX
- Product NDC
- 71104-966
- 11-digit product format
- 711040966
- Labeler code
- 71104
- Product ID
- 71104-966_24887518-9870-451a-9db5-b03dc5571c19
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Coagulation Factor IX (Recombinant), Fc Fusion Protein
- Dosage form
- KIT
- Labeler
- Bioverativ Therapeutics Inc.
- Application
- BLA125444
- Marketing category
- BLA
- Marketing start
- 2014-05-05
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALPROLIX
- Listing expiration
- 2026-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71104-952-01 | ALPROLIX | 5 mL in 1 VIAL | POWDER, FOR SOLUTION | 5 mL | 250 [iU] in 5mL | 12 |
| 71104-966-01 | ALPROLIX | 1 in 1 CARTON | KIT | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71104-966 | ALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOVERATIV THERAPEUTICS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240517_2fb3fb92-379d-4683-80d6-b06c0a7dc063.zip |
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 |
|---|
| 71104-952-01 | 71104095201 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 71104-966-01 | 71104096601 | 1 KIT in 1 CARTON (71104-966-01) * 5 mL in 1 VIAL (71104-952-01) * 5 mL in 1 VIAL (71104-045-01) | 1 kit | 2014-05-05 | 0000-00-00 | No | No | Current |