Kimyrsa
- Product NDC
- 70842-225
- 11-digit product format
- 708420225
- Labeler code
- 70842
- Product ID
- 70842-225_25ae2ae5-afce-4475-bf3c-45323e93a952
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oritavancin diphosphate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Melinta Therapeutics, LLC
- Application
- NDA214155
- Marketing category
- NDA
- Marketing start
- 2021-03-23
- Substance
- ORITAVANCIN DIPHOSPHATE
- Active strength
- 1200 mg/40mL
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kimyrsa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ORITAVANCIN DIPHOSPHATE | 1200 mg/40mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VL1P93MKZN |
| Rxcui | 2532361, 2532366 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70842-225-01 | Kimyrsa | 40 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 40 | | 7 |
| 70842-225-01 | Kimyrsa | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70842-225 | KIMYRSA (ORITAVANCIN DIPHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250508_5e755c40-6e73-4572-b474-4d8a131693d1.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 |
|---|
| 70842-225-01 | 70842022501 | 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL | 1 vial | 2021-03-23 | 0000-00-00 | No | No | Current |