daptomycin
- Product NDC
- 70436-033
- 11-digit product format
- 704360033
- Labeler code
- 70436
- Product ID
- 70436-033_e6b9cc81-2724-1ecb-e053-2995a90a13c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- daptomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA215890
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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 |
|---|
| 70436-033-80 | 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 |
|---|
| 70436-033 | DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221001_3890474a-4425-43b3-97d4-5370cc35c2f7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70436-033-80 | 70436003380 | 20 mL in 1 VIAL, SINGLE-DOSE (70436-033-80) | 20 ml | 2022-10-01 | 0000-00-00 | No | No | Current |