VIBATIV
- Product NDC
- 66220-315
- 11-digit product format
- 662200315
- Labeler code
- 66220
- Product ID
- 66220-315_7664f8a4-33c4-4f30-998e-86333640c44d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telavancin hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cumberland Pharmaceuticals Inc.
- Application
- NDA022110
- Marketing category
- NDA
- Marketing start
- 2021-01-01
- Substance
- TELAVANCIN HYDROCHLORIDE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIBATIV
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TELAVANCIN HYDROCHLORIDE | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0701472ZG0 |
| Rxcui | 1728082, 1728085 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66220-315-11 | VIBATIV | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 66220-315-11 | VIBATIV | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 6 |
| 66220-315-22 | VIBATIV | 12 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 12 | | 6 |
| 66220-315-22 | VIBATIV | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 6 |
| 66220-315-44 | VIBATIV | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 6 |
| 66220-315-44 | VIBATIV | 4 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66220-315 | VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20231205_5359b759-db7c-4672-9e8a-59c93869bd91.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 |
|---|
| 66220-315-11 | 66220031511 | 1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE | 2021-01-01 | 0000-00-00 | No | No | Current |
| 66220-315-22 | 66220031522 | 12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE | 2021-01-01 | 0000-00-00 | No | No | Current |
| 66220-315-44 | 66220031544 | 4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE | 2023-12-01 | | No | No | Current |