Orbactiv is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Oritavancin.
Product ID | 65293-015_60ef4da8-d132-f2fe-e053-2a91aa0a4005 |
NDC | 65293-015 |
Product Type | Human Prescription Drug |
Proprietary Name | Orbactiv |
Generic Name | Oritavancin |
Dosage Form | Injection, Powder, Lyophilized, For Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2014-09-01 |
Marketing End Date | 2021-06-30 |
Marketing Category | NDA / NDA |
Application Number | NDA206334 |
Labeler Name | The Medicines Company |
Substance Name | ORITAVANCIN |
Active Ingredient Strength | 400 mg/1 |
Pharm 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 | N |
Marketing Start Date | 2014-09-01 |
Marketing End Date | 2021-06-30 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA206334 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2014-09-01 |
Marketing End Date | 2021-06-30 |
Marketing Category | NDA |
Application Number | NDA206334 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2014-09-01 |
Marketing End Date | 2021-06-30 |
Inactivation Date | 2020-01-31 |
Reactivation Date | 2020-02-11 |
Ingredient | Strength |
---|---|
ORITAVANCIN | 400 mg/1 |
SPL SET ID: | 085d6d1a-21c2-11e4-8c21-0800200c9a66 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
65293-015 | Orbactiv | oritavancin |
70842-140 | Orbactiv | oritavancin |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORBACTIV 86120316 4664703 Live/Registered |
MELINTA THERAPEUTICS, INC. 2013-11-15 |