Orbactiv
- Product NDC
- 70842-140
- 11-digit product format
- 708420140
- Labeler code
- 70842
- Product ID
- 70842-140_4c7649f3-4d38-47e2-aa0d-2ed606bb930a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oritavancin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Melinta Therapeutics, LLC
- Application
- NDA206334
- Marketing category
- NDA
- Marketing start
- 2014-09-01
- Substance
- ORITAVANCIN
- Active strength
- 400 mg/1
- 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
- Orbactiv
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ORITAVANCIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PUG62FRZ2E |
| Rxcui | 1547615, 1547620 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70842-140-01 | Orbactiv | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
| 70842-140-03 | Orbactiv | 3 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 3 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70842-140 | ORBACTIV (ORITAVANCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241222_ff09a726-9f9b-4e30-b509-396781293220.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 |
|---|
| 70842-140-01 | 70842014001 | 1 in 1 VIAL, GLASS | | | | | Historical |
| 70842-140-03 | 70842014003 | 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01) | 2014-09-01 | 0000-00-00 | No | No | Current |