Vibativ
- Product NDC
- 52118-002
- 11-digit product format
- 521180002
- Labeler code
- 52118
- Product ID
- 52118-002_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telavancin hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Theravance, Inc.
- Application
- NDA022110
- Marketing category
- NDA
- Marketing start
- 2009-11-05
- Marketing end
- 0000-00-00
- Substance
- TELAVANCIN HYDROCHLORIDE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52118-002-01 | Vibativ | 1 in 1 CONTAINER | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 52118-002-01 | Vibativ | 17 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 17 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| telavancin hydrochloride | ACTIVE INGREDIENT | 0701472ZG0 | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.] | 9 | |
| telavancin | ACTIVE MOIETY | XK134822Z0 | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.] | 9 | |
| Hydroxypropylbetadex (0.58-0.68 MS) | INACTIVE INGREDIENT | 1I96OHX6EK | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.] | 9 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52118-002 | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAVANCE, INC.] | 9 | Legacy NDC, 2 package rows | 20140402_9fc67b76-9ba1-45ec-9749-ca3f3a6477d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52118-002-01 | 52118000201 | 1 in 1 CONTAINER | Historical |