Daptomycin
- Product NDC
- 0143-9444
- 11-digit product format
- 001439444
- Labeler code
- 0143
- Product ID
- 0143-9444_a423fe8f-86a1-4abc-9750-70ab3485b89a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206005
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- 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 |
|---|
| 0143-9444-01 | Daptomycin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 3 |
| 0143-9444-01 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9444-01 | 00143944401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9444-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-09-30 | No | No | Current |