Daptomycin
- Product NDC
- 16714-892
- 11-digit product format
- 167140892
- Labeler code
- 16714
- Product ID
- 16714-892_92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- NorthStar RxLLC
- Application
- ANDA208375
- Marketing category
- ANDA
- Marketing start
- 2022-06-13
- Marketing end
- 2026-06-30
- Substance
- DAPTOMYCIN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daptomycin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPTOMYCIN | 50 mg/mL |
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 |
|---|
| 16714-892-01 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 16714-892-01 | Daptomycin | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 15 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-892 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241204_1c5dee92-299e-26f6-6332-e6a8fd376526.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 |
|---|
| 16714-892-01 | 16714089201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) / 15 mL in 1 VIAL, SINGLE-DOSE | 2022-06-13 | 2026-06-30 | No | No | Current |