Daptomycin
- Product NDC
- 43598-476
- 11-digit product format
- 435980476
- Labeler code
- 43598
- Product ID
- 43598-476_29677998-337b-a026-92f5-1a3958dec926
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc.,
- Application
- ANDA211403
- Marketing category
- ANDA
- Marketing start
- 2021-10-04
- Substance
- DAPTOMYCIN
- Active strength
- 350 mg/7mL
- 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 | 350 mg/7mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NWQ5N31VKK |
| Rxcui | 1996246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-476-11 | Daptomycin | 7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7 | | 7 |
| 43598-476-11 | Daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 43598-476-58 | Daptomycin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 7 |
| 43598-476-58 | Daptomycin | 7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-476 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.,] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231101_d750e28d-1353-4671-66a3-ea4e49e81e7b.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 |
|---|
| 43598-476-11 | 43598047611 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-11) / 7 mL in 1 VIAL, SINGLE-DOSE | 2021-10-04 | 0000-00-00 | No | No | Current |
| 43598-476-58 | 43598047658 | 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-58) / 7 mL in 1 VIAL, SINGLE-DOSE | 2021-10-04 | 0000-00-00 | No | No | Current |