Active ingredient
Vancomycin
153 finished FDA listings contain Vancomycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VANCOMYCIN, VANCOMYCIN HYDROCHLORIDE
- Dosage forms
- Capsule, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Powder, For Solution, Solution
- Routes
- Intravenous, Intravitreal, Oral
- Manufacturers / labelers
- 34
- Strengths listed
- 1 g/1 · 1 g/200ml · 1 g/20ml · 1.25 g/1 · 1.25 g/250ml · 1.25 g/25ml · 1.25 g/30ml · 1.5 g/1 · 1.5 g/300ml · 1.5 g/30ml · 1.75 g/350ml · 1.75 g/35ml · 10 g/1 · 10 g/100ml · 10 g/95ml · 10.25 g/g · 100 g/1 · 1025 mg/mg · 125 mg/1 · 1280 mg/mg · 1540 mg/mg · 2 g/400ml · 2 g/40ml · 250 mg/1 · 250 mg/5ml · 5 g/1 · 5 g/100ml · 5.13 g/g · 500 mg/1 · 500 mg/100ml · 500 mg/10ml · 500 mg/5ml · 513 mg/mg · 750 mg/1 · 750 mg/150ml · 750 mg/15ml · 750 mg/20ml · 769 mg/mg
- Brand names in FDA listings
- Tyzavan, Vancocin, Vancomycin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 11124
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 | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 061667 | ANI PHARMS | 1983-07-13 | 7 |
| NDA 050606 | ANI PHARMS | 1986-04-15 | 6 |
| ANDA 062663 | FRESENIUS KABI USA | 1987-03-17 | 11 |
| ANDA 062912 | HOSPIRA | 1988-08-04 | 5 |
| ANDA 062911 | HOSPIRA | 1988-08-04 | 2 |
| ANDA 063076 | HOSPIRA | 1990-12-21 | 5 |
| NDA 050671 | BAXTER HLTHCARE | 1993-04-29 | 8 |
| ANDA 065401 | EUROFARMA | 2008-06-30 | 2 |
| ANDA 065397 | MYLAN LABS LTD | 2008-12-30 | 2 |
| ANDA 065432 | MYLAN LABS LTD | 2008-12-30 | 1 |
| ANDA 090250 | PLANO PHARMS | 2010-04-27 | 1 |
| ANDA 091554 | MYLAN LABS LTD | 2011-09-19 | 1 |
| ANDA 065490 | STRIDES PHARMA | 2012-04-09 | 5 |
| ANDA 065478 | PAI HOLDINGS | 2012-04-09 | 2 |
| ANDA 200837 | SAGENT PHARMS | 2012-08-10 | 2 |
| ANDA 201048 | PLANO PHARMS | 2012-08-10 | 1 |
| ANDA 204125 | XELLIA PHARMS APS | 2015-12-28 | 3 |
| ANDA 204107 | HIKMA | 2015-12-28 | 3 |
| ANDA 091532 | SAMSON MEDCL | 2016-01-06 | 1 |
| ANDA 205694 | GLAND | 2016-01-21 | 10 |
| ANDA 205779 | EUGIA PHARMA | 2016-03-29 | 2 |
| ANDA 205780 | EUGIA PHARMA | 2016-03-31 | 2 |
| NDA 209481 | MYLAN LABS LTD | 2018-07-10 | 5 |
| ANDA 206616 | HIKMA PHARMS | 2018-10-03 | 1 |
| ANDA 204360 | HIKMA | 2018-10-15 | 2 |
| NDA 211962 | HIKMA | 2019-02-15 | 14 |
| ANDA 210729 | ORIENT PHARMA CO LTD | 2019-04-29 | 6 |
| ANDA 212332 | HAINAN POLY | 2019-06-12 | 2 |
| ANDA 203300 | HIKMA | 2020-08-11 | 2 |
| ANDA 215821 | HAINAN POLY | 2021-11-18 | 2 |
| ANDA 216591 | ASPIRO | 2022-07-06 | 2 |
| ANDA 215196 | MEITHEAL | 2022-07-27 | 2 |
| ANDA 215197 | MEITHEAL | 2022-07-28 | 2 |
| ANDA 215195 | MEITHEAL | 2022-09-15 | 1 |
| NDA 210274 | ZHEJIANG NOVUS PHARM | 2023-01-20 | 11 |
| ANDA 215338 | AMNEAL | 2023-06-23 | 1 |
| ANDA 217489 | HIKMA | 2023-06-29 | 2 |
| ANDA 217401 | EUGIA PHARMA | 2023-08-04 | 2 |
| ANDA 218140 | GLAND | 2025-03-21 | 9 |
| ANDA 215324 | STERISCIENCE | 2025-10-02 | 5 |
Official labeling on DailyMed
- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] · version 10 · 2026-08-28
- TYZAVAN (VANCOMYCIN) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2026-08-20
- VANCOMYCIN HYDROCHLORIDE CAPSULE [CAMERON PHARMACEUTICALS] · version 6 · 2026-08-19
- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [AVENACY, LLC · version 1 · 2026-08-17
- VANCOMYCIN HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 1 · 2026-08-11
- VANCOMYCIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG] · version 1 · 2026-08-03
- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] · version 19 · 2026-07-22
- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PLANO PHARMACEUTICALS INC.] · version 3 · 2026-07-22
- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 6 · 2026-07-20
- VANCOMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-06-29
- VANCOMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 101 · 2026-06-29
- VANCOMYCIN HYDROCHLORIDE POWDER, FOR SOLUTION [BRYANT RANCH PREPACK] · version 104 · 2026-06-18
Showing the 12 most recent of 76 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.