NDC 71715-001
NUZYRA
Omadacycline
NUZYRA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Paratek Pharmaceuticals, Inc.. The primary component is Omadacycline.
| Product ID | 71715-001_3d8a724a-2af8-402b-abf5-5844e7bdaf2b |
| NDC | 71715-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | NUZYRA |
| Generic Name | Omadacycline |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-02-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA209817 |
| Labeler Name | Paratek Pharmaceuticals, Inc. |
| Substance Name | OMADACYCLINE |
| Active Ingredient Strength | 100 mg/5mL |
| Pharm Classes | Tetracycline-class Antibacterial [EPC],Tetracyclines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 71715-001-02
10 VIAL, GLASS in 1 CARTON (71715-001-02) > 10 mL in 1 VIAL, GLASS (71715-001-01)
| Marketing Start Date | 2019-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71715-001-01 [71715000101]
NUZYRA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA209817 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-01 |
NDC 71715-001-02 [71715000102]
NUZYRA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA209817 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-02-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OMADACYCLINE | 100 mg/5mL |
OpenFDA Data
| SPL SET ID: | 51591524-4703-44c6-8bde-dce3e6a463d1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "NUZYRA" or generic name "Omadacycline"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71715-001 | NUZYRA | omadacycline |
| 71715-002 | NUZYRA | omadacycline |
Trademark Results [NUZYRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUZYRA 88438211 not registered Live/Pending |
Paratek Pharmaceuticals, Inc. 2019-05-20 |
 NUZYRA 87908478 5741452 Live/Registered |
Paratek Pharmaceuticals, Inc. 2018-05-04 |
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