DAPTOMYCIN
- Product NDC
- 71288-017
- 11-digit product format
- 712880017
- Labeler code
- 71288
- Product ID
- 71288-017_0d079f8d-94fb-4532-802c-415127d718de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPTOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213786
- Marketing category
- ANDA
- Marketing start
- 2021-06-29
- 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 |
|---|
| 71288-017-15 | DAPTOMYCIN | 7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7 | | 8 |
| 71288-017-15 | DAPTOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 71288-017-91 | DAPTOMYCIN | 7 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7 | | 4 |
| 71288-017-91 | DAPTOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-017 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20220504_4f39cddc-1cb7-41d4-a657-07f7903ee24f.zip |
| 71288-017 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220507_191f0224-67b7-4945-bdcd-38d60645e38c.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 |
|---|
| 71288-017-15 | 71288001715 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-017-15) / 7 mL in 1 VIAL, SINGLE-DOSE | 2021-06-29 | 0000-00-00 | No | No | Current |
| 71288-017-91 | 71288001791 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-017-91) / 7 mL in 1 VIAL, SINGLE-DOSE | 2022-04-05 | 0000-00-00 | No | No | Current |