Vancomycin Hydrochloride

Treats Clostridioides difficile -associated diarrhea. Sold as Vancocin Hydrochloride, Vancomycin Hydrochloride In Plastic Container, Firvanq, Vancomycin Hydrochloride, Tyzavan. Every FDA application for this active ingredient: 6 branded and 61 generic.

As of Nov 15, 2026, FDA lists 67 applications for Vancomycin Hydrochloride (sold as Vancocin Hydrochloride, Vancomycin Hydrochloride In Plastic Container, Firvanq and others), first approved Apr 29, 1993, with 5 new uses approved and 3 published complete response letters.

First approved: Apr 29, 1993
Applications: 67
New uses approved: 5
Complete response letters: 3
Medicare spending, 2025: $607K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Firvanq	Part D	$335K	-34%	1,061
Vancocin HCl	Part D	$267K	-36%	21
VANCOMYCIN HCL(J3374)	Part B	$3K	New	49
Vancomycin HCL (J3371)	Part B	$2K	-99%	12

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

VANCOMYCIN 25 MG/ML ORAL SOLN: $0.397 per MLGeneric · -5% in a year
VANCOMYCIN 250 MG/5 ML ORAL SOL: $0.801 per MLGeneric · +0% in a year
VANCOMYCIN 50 MG/ML ORAL SOLN: $0.727 per MLGeneric · 0% in a year
VANCOMYCIN 500 MG VIAL: $2.31 per unitGeneric · +0% in a year
VANCOMYCIN HCL 125 MG CAPSULE: $1.21 per unitGeneric · -9% in a year
VANCOMYCIN HCL 250 MG CAPSULE: $2.25 per unitGeneric · +9% in a year
FIRVANQ 50 MG/ML SOLUTION: $1.19 per MLBrand · +3% in a year

Orphan Designations (FDA)

4 designations, 0 approved for the designated use; see all orphan designations

Treatment of periprosthetic joint infectionForCast Orthopedics, Inc. · designated Jun 22, 2023
Treatment of periprosthetic joint infectionOsteal Therapeutics, Inc. · designated Mar 17, 2022
Treatment of endophthalmitisFera Pharmaceuticals, LLC · designated Dec 27, 2012
Treatment of persistent methicillin-resistant S. aureus lung infection in patients with cystic fibrosisSavara Inc. · designated Sep 20, 2012

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Vancomycin HydrochlorideA drug with new additional indications for the treatment of: (1) sepsis, infective endocarditis, secondary infection of trauma, burn or surgical wounds,… · Shionogi & Co., Ltd. · May 23, 2014
Vancomycin, new approvalA drug with a new route of administration indicated for the treatment of conjunctivitis, blepharitis, meibomianitis, and dacryocystitis caused by… · Toa Pharmaceutical Co., Ltd. · Oct 16, 2009

Clinical Trials

133 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Ceftazidime Safety and Efficacy in the Prevention of Surgical Site InfectionsThoracolumbar Spinal Fusion · University of Utah	Phase 2	Enrolling by invitation	Nov 12, 2026
Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of InfectionTibial Fractures, Fractures, Open · Reselute, Inc.	Not applicable	Not yet recruiting	Nov 10, 2026
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate · Metagen Therapeutics, Inc.	Phase 1 / Phase 2	Recruiting	Nov 3, 2026
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial FluidBiomarkers, Acute Kidney Injury · Nutromics	—	Not yet recruiting	Oct 23, 2026
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.Nephrotoxicity, Acute Kidney Injuries · Ain Shams University	Not applicable	Enrolling by invitation	Oct 14, 2026
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI ParticipantsProsthetic Joint Infection (PJI) · TenNor Therapeutics (Zhongshan) Limited	Phase 2	Recruiting	Oct 5, 2026
Exploring the Combination of Intracalvariosseous and Intravenous Antibiotics for Moderate to Severe Bacterial MeningitisBlood-Brain Barrier, Bacterial Meningitis · yilong Wang	Not applicable	Not yet recruiting	Sep 17, 2026
Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-CNephrotoxicity, Bacterial Infections · King Faisal Specialist Hospital & Research Center	—	Recruiting	Sep 14, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 6, 1964	Vancocin HydrochlorideANDA 60180	Steriscience	16	Discontinued
Jul 13, 1983	Vancocin HydrochlorideANDA 61667	Ani Pharms	8	Marketed
Mar 21, 1986	Vancocin HydrochlorideANDA 62476	Steriscience	10	Discontinued
Jul 22, 1986	VancoledANDA 62682	Hikma	13	Discontinued
Mar 13, 1987	Vancocin HydrochlorideANDA 62716	Steriscience	12	Discontinued
Mar 17, 1987	Vancomycin HydrochlorideANDA 62663	Fresenius Kabi USA	34	Marketed
Nov 17, 1987	Vancocin HydrochlorideANDA 62812	Steriscience	11	Discontinued
Aug 2, 1988	Vancomycin HydrochlorideANDA 62879	Hikma	15	Discontinued
Aug 4, 1988	Vancomycin HydrochlorideANDA 62911	Hospira	19	Marketed
Aug 4, 1988	Vancomycin HydrochlorideANDA 62912	Hospira	18	Marketed
Dec 21, 1990	Vancomycin HydrochlorideANDA 63076	Hospira	13	Marketed
Oct 29, 1992	Vancomycin HydrochlorideANDA 62933	Hospira	18	Marketed
Oct 29, 1992	Vancomycin HydrochlorideANDA 62931	Hospira	16	Marketed
Apr 29, 1993	Vancomycin Hydrochloride In Plastic ContainerNDA 50671 · New dosage form	Baxter Hlthcare	18	Marketed
Oct 15, 1993	VancoledANDA 63321	Lederle	2	Discontinued
Mar 17, 2004	Vancocin HydrochlorideNDA 50606	Ani Pharms	21	Marketed
Jun 30, 2008	Vancomycin HydrochlorideANDA 65401	Eurofarma	6	Marketed
Dec 30, 2008	Vancomycin HydrochlorideANDA 65432	Mylan Labs Ltd	7	Marketed
Dec 30, 2008	Vancomycin HydrochlorideANDA 65397	Mylan Labs Ltd	11	Marketed
Apr 29, 2009	Vancomycin HydrochlorideANDA 65455	Hospira Inc	3	Discontinued
Apr 27, 2010	Vancomycin HydrochlorideANDA 90250	Plano Pharms	0	Discontinued
Jul 1, 2011	Vancomycin HydrochlorideANDA 91469	Mylan Labs Ltd	2	Discontinued
Sep 19, 2011	Vancomycin HydrochlorideANDA 91554	Mylan Labs Ltd	6	Marketed
Apr 9, 2012	Vancomycin HydrochlorideANDA 65478	Pai Holdings	2	Marketed
Apr 9, 2012	Vancomycin HydrochlorideANDA 65510	Watson Labs	0	Discontinued
Apr 9, 2012	Vancomycin HydrochlorideANDA 65490	Strides Pharma	4	Marketed
Jun 18, 2012	Vancomycin HydrochlorideANDA 65453	Fresenius Kabi USA	1	Discontinued
Aug 10, 2012	Vancomycin HydrochlorideANDA 200837	Sagent Pharms	3	Marketed
Aug 10, 2012	Vancomycin HydrochlorideANDA 201048	Plano Pharms	3	Discontinued
Oct 9, 2013	Vancomycin HydrochlorideANDA 202464	Avet Lifesciences	3	Discontinued
Oct 31, 2013	Vancomycin HydrochlorideANDA 202274	Avet Lifesciences	3	Discontinued
Oct 31, 2013	Vancomycin HydrochlorideANDA 202275	Avet Lifesciences	4	Discontinued
Jan 28, 2015	Vancomycin HydrochlorideANDA 90439	Lupin	5	Discontinued
Sep 9, 2015	Vancomycin HydrochlorideANDA 91377	Xellia Pharms Aps	0	Discontinued
Dec 23, 2015	Vancomycin HydrochlorideANDA 201250	Teva Pharms USA	0	Discontinued
Dec 23, 2015	Vancomycin HydrochlorideANDA 201251	Teva Pharms USA	0	Discontinued
Dec 23, 2015	Vancomycin HydrochlorideANDA 206243	Xellia Pharms Aps	0	Discontinued
Dec 28, 2015	Vancomycin HydrochlorideANDA 204107	Hikma	3	Marketed
Dec 28, 2015	Vancomycin HydrochlorideANDA 204125	Xellia Pharms Aps	2	Marketed
Jan 6, 2016	Vancomycin HydrochlorideANDA 91532	Samson Medcl	2	Marketed
Jan 21, 2016	Vancomycin HydrochlorideANDA 205694	Gland	4	Marketed
Mar 29, 2016	Vancomycin HydrochlorideANDA 205779	Eugia Pharma	0	Marketed
Mar 31, 2016	Vancomycin HydrochlorideANDA 205780	Eugia Pharma	2	Marketed
Jan 26, 2018	FirvanqNDA 208910 · New formulation or manufacturer	Azurity	3	Marketed
Jul 10, 2018	Vancomycin HydrochlorideNDA 209481 · New formulation or manufacturer	Mylan Labs Ltd	4	Marketed
Oct 3, 2018	Vancomycin HydrochlorideANDA 206616	Hikma Pharms	2	Marketed
Oct 15, 2018	Vancomycin HydrochlorideANDA 204360	Hikma	2	Marketed
Feb 15, 2019	TyzavanNDA 211962 · New formulation or manufacturer	Hikma	6	Marketed
Apr 29, 2019	Vancomycin HydrochlorideANDA 210729	Orient Pharma Co Ltd	1	Marketed
Jun 12, 2019	Vancomycin HydrochlorideANDA 212332	Hainan Poly	1	Marketed
Aug 11, 2020	Vancomycin HydrochlorideANDA 203300	Hikma	1	Marketed
Nov 18, 2021	Vancomycin HydrochlorideANDA 215821	Hainan Poly	0	Marketed
Feb 15, 2022	Vancomycin HydrochlorideANDA 213059	Knack	0	Discontinued
Jul 6, 2022	Vancomycin HydrochlorideANDA 216591	Aspiro	0	Marketed
Jul 27, 2022	Vancomycin HydrochlorideANDA 215196	Meitheal	0	Marketed
Jul 28, 2022	Vancomycin HydrochlorideANDA 215197	Meitheal	0	Marketed
Sep 15, 2022	Vancomycin HydrochlorideANDA 215195	Meitheal	0	Marketed
Nov 14, 2022	Vancomycin HydrochlorideANDA 214913	Alkem Labs Ltd	0	Marketed
Jan 20, 2023	Vancomycin HydrochlorideNDA 210274 · New formulation or manufacturer	Zhejiang Novus Pharm	2	Marketed
Jun 23, 2023	Vancomycin HydrochlorideANDA 215338	Amneal	0	Discontinued
Jun 29, 2023	Vancomycin HydrochlorideANDA 217489	Hikma	0	Marketed
Aug 4, 2023	Vancomycin HydrochlorideANDA 217401	Eugia Pharma	0	Marketed
Mar 21, 2025	Vancomycin HydrochlorideANDA 218140	Gland	0	Marketed
Oct 2, 2025	Vancomycin HydrochlorideANDA 215324	Steriscience	0	Marketed
Aug 7, 2026	Vancomycin HydrochlorideANDA 218130	Aurobindo Pharma	0	Marketed
—	Vancomycin HclANDA 62845	Quad Pharms	0	Discontinued
—	VancorANDA 62956	Pharmacia And Upjohn	0	Discontinued

Show all 67

Complete Response Letters

FDA's published letters for these applications


Aug 25, 2021	Vancomycin HydrochlorideFacility Inspections	Approved
Nov 27, 2020	Vancomycin HydrochlorideFacility Inspections	Approved
Jun 15, 2018	Vancomycin HydrochlorideProduct Quality	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA