daptomycin
- Product NDC
- 67457-941
- 11-digit product format
- 674570941
- Labeler code
- 67457
- Product ID
- 67457-941_9298852c-a9c3-4787-8dec-919dd666c968
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA213966
- Marketing category
- ANDA
- Marketing start
- 2023-11-27
- 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 |
|---|
| 67457-941-15 | daptomycin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
| 67457-941-15 | 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 |
|---|
| 67457-941 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 1 | Current NDC, 2 package rows | 20231128_95909792-972b-4c0c-b2ce-2be4bed36cff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67457-941-15 | 67457094115 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-941-15) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-11-27 | No | No | Current |