Daptomycin
- Product NDC
- 70594-034
- 11-digit product format
- 705940034
- Labeler code
- 70594
- Product ID
- 70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA206005
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- Substance
- DAPTOMYCIN
- Active strength
- 500 mg/10mL
- Pharmacologic classes
- Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daptomycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPTOMYCIN | 500 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NWQ5N31VKK |
| Rxcui | 403920 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-034-01 | Daptomycin | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 14 |
| 70594-034-01 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
| 70594-034-02 | Daptomycin | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
| 70594-034-02 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-034 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231118_494b2aa1-020b-432c-977e-a5d74e31e342.zip |
| 70594-034 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230805_fc7eef03-042b-44a1-a344-1fa8a0435900.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70594-034-01 | 70594003401 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01) / 10 mL in 1 VIAL, SINGLE-USE | 2018-10-01 | 0000-00-00 | No | No | Current |
| 70594-034-02 | 70594003402 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-02) / 10 mL in 1 VIAL, SINGLE-USE | 2021-05-01 | 0000-00-00 | No | No | Current |