daptomycin
- Product NDC
- 25021-174
- 11-digit product format
- 250210174
- Labeler code
- 25021
- Product ID
- 25021-174_a3f62ffc-f089-4f4c-bad1-99f60f1d88b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA207104
- Marketing category
- ANDA
- Marketing start
- 2019-11-15
- Substance
- DAPTOMYCIN
- Active strength
- 50 mg/mL
- 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 | 50 mg/mL |
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 |
|---|
| 25021-174-15 | daptomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 15 |
| 25021-174-15 | daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
| 25021-174-16 | daptomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 15 |
| 25021-174-16 | daptomycin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-174 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 15 | Current NDC, Legacy NDC, 4 package rows | 20230523_f4ad8613-f25e-4b82-9621-cc5ff9525d3e.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 |
|---|
| 25021-174-15 | 25021017415 | 1 VIAL in 1 CARTON (25021-174-15) / 10 mL in 1 VIAL | 1 vial | 2019-11-15 | 0000-00-00 | No | No | Current |
| 25021-174-16 | 25021017416 | 10 VIAL in 1 CARTON (25021-174-16) / 10 mL in 1 VIAL | 10 vial | 2019-11-15 | 0000-00-00 | No | No | Current |