NDC 71773-050
Xerava
Eravacycline
Xerava is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Tetraphase Pharmaceuticals, Inc.. The primary component is Eravacycline Dihydrochloride.
| Product ID | 71773-050_47ef366a-a414-4fbf-b5b2-22c12422b520 |
| NDC | 71773-050 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Xerava |
| Generic Name | Eravacycline |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-09-10 |
| Marketing Category | NDA / NDA |
| Application Number | NDA211109 |
| Labeler Name | Tetraphase Pharmaceuticals, Inc. |
| Substance Name | ERAVACYCLINE DIHYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Tetracycline-class Antibacterial [EPC],Tetracyclines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 71773-050-05
1 VIAL, GLASS in 1 CARTON (71773-050-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
| Marketing Start Date | 2018-09-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 71773-050-05 [71773005005]
Xerava INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA211109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-10 |
NDC 71773-050-12 [71773005012]
Xerava INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA211109 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-10 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ERAVACYCLINE DIHYDROCHLORIDE | 50 mg/1 |
OpenFDA Data
| SPL SET ID: | a4b188d4-f467-470c-ad7b-25ffbdd8862a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Xerava" or generic name "Eravacycline"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 71773-050 | Xerava | eravacycline |
| 71773-100 | Xerava | eravacycline |
Trademark Results [Xerava]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XERAVA 87782461 not registered Live/Pending |
Tetraphase Pharmaceuticals, Inc. 2018-02-02 |
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