Active ingredient
Dalbavancin
7 finished FDA listings contain Dalbavancin as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- DALBAVANCIN, DALBAVANCIN HYDROCHLORIDE
- Dosage forms
- Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 7
- Strengths listed
- 500 mg/1 · 500 mg/25ml
- Brand names in FDA listings
- Dalbavancin, Dalvance
Official drug information
Source coverage for Dalbavancin:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1539239
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 021883
- Sponsor
- ABBVIE
- Original approval
- 2014-05-23
- Listings
- 1
- Application
- ANDA 219465
- Sponsor
- TEVA PHARMS INC
- Original approval
- 2025-10-23
- Listings
- 1
- Application
- ANDA 217591
- Sponsor
- FRESENIUS KABI USA
- Original approval
- 2025-11-10
- Listings
- 1
- Application
- ANDA 218929
- Sponsor
- KINDOS
- Original approval
- 2025-11-26
- Listings
- 1
- Application
- ANDA 218602
- Sponsor
- LONG GROVE PHARMS
- Original approval
- 2026-02-26
- Listings
- 1
- Application
- ANDA 219604
- Sponsor
- BE PHARMS
- Original approval
- 2026-06-04
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021883 | ABBVIE | 2014-05-23 | 1 |
| ANDA 219465 | TEVA PHARMS INC | 2025-10-23 | 1 |
| ANDA 217591 | FRESENIUS KABI USA | 2025-11-10 | 1 |
| ANDA 218929 | KINDOS | 2025-11-26 | 1 |
| ANDA 218602 | LONG GROVE PHARMS | 2026-02-26 | 1 |
| ANDA 219604 | BE PHARMS | 2026-06-04 | 2 |
Official labeling on DailyMed
- DALBAVANCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 1 · 2026-07-30
- DALBAVANCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BE PHARMACEUTICALS INC.] · version 5 · 2026-06-15
- DALBAVANCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 2 · 2026-04-16
- DALBAVANCIN (DALBAVANCIN HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [LONG GROVE PHARMACEUTICALS, LLC] · version 2 · 2026-03-03
- DALBAVANCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC] · version 5 · 2025-12-04
- DALBAVANCIN INJECTION, POWDER, FOR SOLUTION [TEVA PHARMACEUTICALS, INC.] · version 3 · 2025-11-18
- DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [ALLERGAN, INC.] · version 29 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.