VYXEOS
- Product NDC
- 68727-745
- 11-digit product format
- 687270745
- Labeler code
- 68727
- Product ID
- 68727-745_25abb1d8-f921-4aae-8240-1914cd80417a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- (daunorubicin and cytarabine) liposome
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Jazz Pharmaceuticals, Inc.
- Application
- NDA209401
- Marketing category
- NDA
- Marketing start
- 2017-08-03
- Substance
- CYTARABINE; DAUNORUBICIN
- Active strength
- 100; 44 mg/20mL; mg/20mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VYXEOS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYTARABINE | 100 mg/20mL |
| DAUNORUBICIN | 44 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04079A1RDZ, ZS7284E0ZP |
| Rxcui | 1942743, 1942748 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68727-745-01 | 2023-10-27 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-02 | 2023-10-27 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-05 | 2023-10-27 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-01 | 2023-07-28 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-02 | 2023-07-28 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-05 | 2023-07-28 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-02 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
| 68727-745-05 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b45-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68727-745-01 | VYXEOS | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 14 |
| 68727-745-02 | VYXEOS | 40 mL in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 40 | | 14 |
| 68727-745-05 | VYXEOS | 100 mL in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 100 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68727-745 | VYXEOS ((DAUNORUBICIN AND CYTARABINE) LIPOSOME) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [JAZZ PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20241009_7ea701ce-e7d3-4349-a9c2-642a501d45c8.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 |
|---|
| 68727-745-01 | 68727074501 | 20 mL in 1 VIAL (68727-745-01) | 20 ml | 2017-08-03 | 0000-00-00 | No | No | Current |
| 68727-745-02 | 68727074502 | 40 mL in 1 CARTON (68727-745-02) | 40 ml | 2017-08-03 | 0000-00-00 | No | No | Current |
| 68727-745-05 | 68727074505 | 100 mL in 1 CARTON (68727-745-05) | 100 ml | 2017-08-03 | 0000-00-00 | No | No | Current |