Orbactiv
- Product NDC
- 65293-015
- 11-digit product format
- 652930015
- Labeler code
- 65293
- Product ID
- 65293-015_9edb5ed1-a97b-1af3-e053-2a95a90a722e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oritavancin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- The Medicines Company
- Application
- NDA206334
- Marketing category
- NDA
- Marketing start
- 2014-09-01
- Marketing end
- 2021-06-30
- Substance
- ORITAVANCIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65293-015-03 | 65293001503 | 3 VIAL, GLASS in 1 CARTON (65293-015-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01) | 2014-09-01 | 2021-06-30 | No | No | Current |