Daptomycin
- Product NDC
- 16729-434
- 11-digit product format
- 167290434
- Labeler code
- 16729
- Product ID
- 16729-434_40bc42f7-4d83-0e17-e063-6394a90ad5d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA212667
- Marketing category
- ANDA
- Marketing start
- 2019-07-16
- 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 |
|---|
| 16729-434-05 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 16729-434-05 | Daptomycin | 7 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 7 | | 9 |
| 16729-434-45 | Daptomycin | 7 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 7 | | 9 |
| 16729-434-45 | Daptomycin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-434 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241108_f69e9306-ffac-41c9-b277-a6d784f2e341.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 |
|---|
| 16729-434-05 | 16729043405 | 1 VIAL in 1 CARTON (16729-434-05) / 7 mL in 1 VIAL | 1 vial | 2019-07-16 | 0000-00-00 | No | No | Current |
| 16729-434-45 | 16729043445 | 10 VIAL in 1 CARTON (16729-434-45) / 7 mL in 1 VIAL | 10 vial | 2020-02-27 | 0000-00-00 | No | No | Current |