DAPTOMYCIN
- Product NDC
- 55150-344
- 11-digit product format
- 551500344
- Labeler code
- 55150
- Product ID
- 55150-344_2106b93b-565c-43f9-9432-c5787c3aab5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPTOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA213171
- Marketing category
- ANDA
- Marketing start
- 2021-09-02
- 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 |
|---|
| 55150-344-01 | DAPTOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 55150-344-01 | DAPTOMYCIN | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-344 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231013_353bfcaa-a0ff-47ab-829a-35ca340f6a08.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 |
|---|
| 55150-344-01 | 55150034401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-344-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2021-09-02 | 0000-00-00 | No | No | Current |