Daptomycin
- Product NDC
- 63323-371
- 11-digit product format
- 633230371
- Labeler code
- 63323
- Product ID
- 63323-371_7b38aacb-d9c9-47db-a6fe-7e7d938fcd69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206077
- Marketing category
- ANDA
- Marketing start
- 2018-04-11
- 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 |
|---|
| 63323-371-10 | Daptomycin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
| 63323-371-10 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 63323-371-19 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 63323-371-19 | 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 |
|---|
| 63323-371 | DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220720_a990141d-7b92-48a5-a41d-1254522e2aa1.zip |
| 63323-371 | DAPTOMYCIN (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230107_fa514937-e025-4ea7-b62a-385eb056ae70.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 |
|---|
| 63323-371-10 | 63323037110 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2018-04-11 | 0000-00-00 | No | No | Current |
| 63323-371-19 | 63323037119 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-19) / 10 mL in 1 VIAL, SINGLE-DOSE | 2018-04-11 | 0000-00-00 | No | No | Current |