daptomycin
- Product NDC
- 71839-107
- 11-digit product format
- 718390107
- Labeler code
- 71839
- Product ID
- 71839-107_41e692d7-587f-a852-e063-6294a90aded1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BE Pharmaceuticals Inc.
- Application
- ANDA212513
- Marketing category
- ANDA
- Marketing start
- 2019-06-26
- 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 |
|---|
| 71839-107-01 | daptomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 71839-107-01 | daptomycin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71839-107 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BE PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220805_4cdf4099-db58-43b8-9fbc-afd997ccfa4b.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 |
|---|
| 71839-107-01 | 71839010701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71839-107-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2019-06-26 | 0000-00-00 | No | No | Current |