Daptomycin
- Product NDC
- 70594-053
- 11-digit product format
- 705940053
- Labeler code
- 70594
- Product ID
- 70594-053_08352c0c-9494-4a27-bc09-ec6a378df233
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- NDA209949
- Marketing category
- NDA
- Marketing start
- 2019-03-15
- Substance
- DAPTOMYCIN
- Active strength
- 350 mg/7mL
- 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 | 350 mg/7mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NWQ5N31VKK |
| Rxcui | 1996246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70594-053-01 | Daptomycin | 7 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 7 | | 5 |
| 70594-053-01 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-053 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240410_97c47c18-985d-4373-88f7-a86ec591ea44.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 |
|---|
| 70594-053-01 | 70594005301 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-053-01) / 7 mL in 1 VIAL, SINGLE-USE | 2019-03-15 | 0000-00-00 | No | No | Current |