DAPTOMYCIN
- Product NDC
- 16729-435
- 11-digit product format
- 167290435
- Labeler code
- 16729
- Product ID
- 16729-435_40bc0f77-d6a8-2765-e063-6294a90a800a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA211961
- Marketing category
- ANDA
- Marketing start
- 2019-06-24
- 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 |
|---|
| 16729-435-05 | DAPTOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 16729-435-05 | DAPTOMYCIN | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-435 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241108_956b068f-5958-49eb-9c9f-3b6e324e77d2.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 |
|---|
| 16729-435-05 | 16729043505 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-435-05) / 10 mL in 1 VIAL, SINGLE-DOSE | 2019-06-24 | 0000-00-00 | No | No | Current |