Jivi
- Product NDC
- 0026-3942
- 11-digit product format
- 000263942
- Labeler code
- 0026
- Product ID
- 0026-3942_15230046-a8a7-4a1c-b279-ae307d278515
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Antihemophilic Factor (Recombinant) Pegylated-aucl
- Dosage form
- KIT
- Labeler
- Bayer HealthCare LLC
- Application
- BLA125661
- Marketing category
- BLA
- Marketing start
- 2018-08-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Jivi
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0026-3942-25 | 2021-09-07 | C162847 | 48780-1 | ba0f9c33-52b5-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use JIVI safely and effectively. See full prescribing information for JIVI. JIVI ® [antihemophilic factor (recombinant), PEGylated-aucl] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2018 |
| 0026-3942-99 | 2021-09-07 | C162847 | 48780-1 | ba0f9c33-52b5-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use JIVI safely and effectively. See full prescribing information for JIVI. JIVI ® [antihemophilic factor (recombinant), PEGylated-aucl] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2018 |
| 0026-3942-25 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-52b5-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use JIVI safely and effectively. See full prescribing information for JIVI. JIVI ® [antihemophilic factor (recombinant), PEGylated-aucl] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2018 |
| 0026-3942-99 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-52b5-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use JIVI safely and effectively. See full prescribing information for JIVI. JIVI ® [antihemophilic factor (recombinant), PEGylated-aucl] lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2018 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0026-3942-25 | Jivi | 1 in 1 BOX | KIT | 1 | | 13 |
| 0026-3942-99 | Jivi | 1 in 1 BOX | KIT | 1 | | 13 |
| 0026-4942-01 | Jivi | 2.5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 2.5 mL | 500 [iU] in 2.5mL | 13 |
| 0026-4942-99 | Jivi | 2.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 2.5 mL | 500 [iU] in 2.5mL | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0026-3942 | JIVI (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED-AUCL) KIT [BAYER HEALTHCARE LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250529_f04e5bd5-d7e2-453b-a407-2616d81a695d.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 |
|---|
| 0026-3942-25 | 00026394225 | 1 KIT in 1 BOX (0026-3942-25) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) | 1 kit | 2018-08-30 | 0000-00-00 | No | No | Current |
| 0026-3942-99 | 00026394299 | 1 KIT in 1 BOX (0026-3942-99) * 2.5 mL in 1 VIAL (0026-4942-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4942-01) | 1 kit | 2018-08-30 | 0000-00-00 | No | No | Current |
| 0026-4942-01 | 00026494201 | 2.5 mL in 1 VIAL, SINGLE-USE | 2.5 ml | | | | | Historical |
| 0026-4942-99 | 00026494299 | 2.5 mL in 1 VIAL | 2.5 ml | | | | | Historical |