DALVANCE
- Product NDC
- 57970-100
- 11-digit product format
- 579700100
- Labeler code
- 57970
- Product ID
- 57970-100_c8fc5d09-57d1-4c85-aa4d-6bde6a25dcab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalbavancin
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Allergan, Inc.
- Application
- NDA021883
- Marketing category
- NDA
- Marketing start
- 2014-05-23
- Substance
- DALBAVANCIN HYDROCHLORIDE
- Active strength
- 500 mg/25mL
- Pharmacologic classes
- 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
- DALVANCE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DALBAVANCIN HYDROCHLORIDE | 500 mg/25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33WDQ7T81E |
| Rxcui | 1539243, 1539248 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 57970-100-01 | 2025-11-07 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2025-11-07 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2024-01-30 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2024-01-30 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2020-07-30 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2020-07-30 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
| 57970-100-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3211-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57970-100-01 | DALVANCE | 1 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 1 | | 29 |
| 57970-100-01 | DALVANCE | 25 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 25 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DALBAVANCIN HYDROCHLORIDE | ACTIVE INGREDIENT | 33WDQ7T81E | DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] | 12 | |
| DALBAVANCIN | ACTIVE MOIETY | 808UI9MS5K | DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] | 12 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57970-100 | DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [ALLERGAN, INC.] | 28 | Current NDC, Legacy NDC, 2 package rows | 20250228_4b4674d8-4d1e-4728-8465-d42ada33fa5c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57970-100-01 | 57970010001 | 1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL | 1 vial | 2014-05-23 | 0000-00-00 | No | No | Current |