daptomycin
- Product NDC
- 14335-120
- 11-digit product format
- 143350120
- Labeler code
- 14335
- Product ID
- 14335-120_0a1a4553-120c-b67d-e063-6294a90a0572
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Hainan Poly Pharm., Co., Ltd.
- Application
- ANDA215890
- Marketing category
- ANDA
- Marketing start
- 2023-11-14
- Substance
- DAPTOMYCIN
- Active strength
- 500 mg/20mL
- 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/20mL |
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 |
|---|
| 14335-120-01 | daptomycin | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14335-120 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [HAINAN POLY PHARM., CO., LTD.] | 1 | Current NDC, 1 package rows | 20231115_6ec53f7e-9a5f-4b24-84e9-c94325750e32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14335-120-01 | 14335012001 | 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01) | 20 ml | 2023-11-14 | No | No | Historical |