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Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution — NDC 71288-0025-75 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution — NDC 71288-025-75 (Billing 71288-0025-75)

by Meitheal Pharmaceuticals Inc. · 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

This is a package of Vancomycin Hydrochloride 5 g/100mL Injection, Powder, Lyophilized, For Solution from Meitheal Pharmaceuticals Inc., marketed since Jul 2022 and currently FDA-listed. It is this product's only package size.

NDC 71288-0025-75
🏷️ FDA NDC (as labeled) 71288-025-75 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Vancomycin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0820-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0805-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71288-025-75
Product NDC 71288-025
11-digit billing NDC 71288002575
NCPDP billing unit EA — each (per item)
RxCUI 239209, 313572
UNII 71WO621TJD
Application # ANDA215196
SPL Set ID 45642a47-4712-4a12-8cf7-ee6c2ab8e6c6
Established class (EPC) Glycopeptide Antibacterial
Chemical class Glycopeptides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-27
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance VANCOMYCIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16280080102125
GCN Seq No 009330
GCN 41283
HICL code 004042
Ingredient (HICL) Vancomycin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1J
Therapeutic class — specific (HIC3) Vancomycin Antibiotics And Derivatives
AHFS code 08:12.28.16
AHFS class Glycopeptide Antibiotics
FDB label name VANCOMYCIN HCL 5 GM VIAL
FDB brand name Vancomycin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009330
  • GCN: 41283
  • GPI-14 (Medi-Span): 16280080102125
  • HICL (First Databank): 004042
  • AHFS class code: 08:12.28.16
  • RxCUI (RxNorm): 239209
Why two NDCs? The FDA registers this code as 71288-025-75 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71288-0025-75. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Glycopeptide Antibacterial class.

Pharmacologic class Glycopeptide Antibacterial
Drug family (ATC) Antibiotics, Glycopeptide antibacterials, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VANCOMYCIN HCL 5 GM VIAL Ingredient Vancomycin Hcl
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic. By IV, it treats serious infections like bloodstream, heart valve, bone, skin and lung infections. By mouth, it treats C. difficile diarrhea and staph infectio...
  • Oral capsules or liquid are usually taken 3 or 4 times a day for about 7 to 10 days. IV doses are given slowly by a healthcare team. Follow your prescriber's directions and finish...
  • With oral vancomycin, nausea, stomach pain, vomiting and low potassium are most common. Call your doctor promptly for hearing changes, ringing in the ears, rash or blisters, less u...
  • Yes. It can cause kidney injury and hearing problems, especially with higher levels, older age, kidney disease, or other drugs that affect these organs. Your care team may check ki...
📖 Read our full Vancomycin guide →
7
Nutrient depletion considerations

Vancomycin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Vancomycin Hydrochloride nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $58.37 $5,837.42 / 100 ml
Medicare drug plans payPart D · Q2 2026 $57.21 $5,720.60 / 100 ml
Medicare Part B allowsASP · J3373 $0.033 / J3373 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)71288-025-75
11-digit billing NDC71288-0025-75
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3373
DescriptorINJECTION, VANCOMYCIN HYDROCHLORIDE, 10 MG
Billing units / pkg500 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 10 MG, so one package = 500 billing units.
Medicare Part B spend (2026 (Q1))$16,041 · 2,740 claims · $5.85 per claim (all NDCs under J3373)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71288-0025-75 You're viewing this Main listing 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-07-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vancomycin Hydrochloride 5 g 00143-9358-01 Hikma 1 injection — AP FDA listed —
Vancomycin Hydrochloride 500 mg/10mL 00409-6509-49 Hospira, 1 vial — AP FDA listed —
Vancomycin 5 g/100mL 25021-0157-99 Sagent 1 bottle — AP FDA listed —
Vancomycin Hydrochloride 5 g 55150-0205-99 Eugia 1 vial — AP FDA listed —
Vancomycin Hydrochloride 5 g/100mL 63323-0295-61 Fresenius 1 bottle — AP FDA listed —
vancomycin hydrochloride 5 g/100mL 67457-0341-05 Mylan 1 vial — AP FDA listed —
Vancomycin Hydrochloride 5 g 68001-0406-73 BluePoint 1 vial — AP FDA listed —
Vancomycin Hydrochloride 5 g/100mL 68083-0569-01 Gland 1 bottle — AP FDA listed —
Vancomycin Hydrochloride 5 g 70436-0022-82 Slate 1 vial — AP FDA listed —
Vancomycin Hydrochloride 5 g/100mLthis 71288-0025-75 Meitheal 1 vial — AP FDA listed —
Vancomycin Hydrochloride 500 mg/10mL 72572-0105-01 Civica, 1 vial — AP FDA listed —
Vancomycin Hydrochloride 5 g/100mL 87188-0203-01 Plano 1 vial — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMeitheal Pharmaceuticals Inc.
Application holderMEITHEAL PHARMACEUTICALS INC
FDA applicationANDA215196 (ANDA)
Labeler code71288
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio158 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin hydrochloride-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.

Vancomycin Hydrochloride for Injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.

Vancomycin Hydrochloride for Injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis . For endocarditis caused by enterococci (e.g., E. faecalis ), Vancomycin Hydrochloride for Injection has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection has been reported to be effective for the treatment of diphtheroid endocarditis.

Vancomycin Hydrochloride for Injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin hydrochloride. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis.

Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin hydrochloride is not effective by the oral route for other types of infections.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The intent of the pharmacy bulk package for this product is for preparation of solutions for intravenous infusion only. Infusion-related events are related to both the concentration and the rate of administration of vancomycin hydrochloride for injection. Concentrations of no more than 5 mg per mL and rates of no more than 10 mg/min, are recommended in adults (see also age-specific recommendations).

In selected patients in need of fluid restriction, a concentration up to 10 mg per mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS ). Infusion-related events may occur, however, at any rate or concentration.

Patients With Normal Renal Function Adults The usual daily intravenous dose is 2 grams divided either as 500 mg every 6 hours or 1 gram every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

Pediatric Patients The usual intravenous dosage of vancomycin hydrochloride for injection is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

Neonates In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes.

In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

Patients With Impaired Renal Function and Elderly Patients Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function.

Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

DOSAGE TABLE FOR VANCOMYCIN HYDROCHLORIDE FOR INJECTION IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al. 1 ) Creatinine Clearance mL/min Vancomycin Hydrochloride for Injection Dose mg/24 h 100 1,545 90 1,390 80 1,235 70 1,080 60 925 50 770 40 620 30 465 20 310 10 155 The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency. The table is not valid for functionally anephric patients.

For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis.

In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended. When only serum creatinine is known, the following formula (based on sex, weight… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 13 words ▾

CONTRAINDICATIONS Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to this antibiotic.

⚠️ Warnings ~2 min read ▾

WARNINGS Infusion Reactions Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest. Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions.

Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients, especially patients with underlying renal impairment, patients with co-morbidities that predispose to renal impairment, and patients receiving concomitant therapy with a drug known to be nephrotoxic.

Ototoxicity Ototoxicity has occurred in patients receiving vancomycin hydrochloride. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside.

Vancomycin hydrochloride should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations. Dosage of vancomycin hydrochloride for injection must be adjusted for patients with renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin hydrochloride.

Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin hydrochloride for injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Clostridium Difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including vancomycin hydrochloride, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Hemorrhagic Occlusive Retinal Vasculitis (HORV) Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin hydrochloride during or after cataract surgery. The safety and efficacy of vancomycin hydrochloride administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials.

Vancomycin hydrochloride is not indicated for the prophylaxis of endophthalmitis.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Infusion-Related Events During or soon after rapid infusion of vancomycin hydrochloride, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY ), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI).

The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin hydrochloride include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment, or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving vancomycin hydrochloride.

Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ). Ototoxicity A few dozen cases of hearing loss associated with vancomycin hydrochloride have been reported. Most of these patients had kidney dysfunction or a pre-existing hearing loss or were receiving concomitant treatment with an ototoxic drug.

Vertigo, dizziness, and tinnitus have been reported rarely. Hematopoietic Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin hydrochloride or after a total dosage of more than 25 grams, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin hydrochloride is discontinued.

Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm 3 ) has been reported rarely. Phlebitis Inflammation at the injection site has been reported.

Miscellaneous Patients have been reported to have had anaphylaxis, drug fever, nausea, chills, eosinophilia, rashes including exfoliative dermatitis, Stevens-Johnson syndrome (see WARNINGS, Severe Dermatologic Reactions ), and vasculitis in association with the administration of vancomycin hydrochloride. Chemical peritonitis has been reported following intraperitoneal administration (see PRECAUTIONS ). Post Marketing Reports The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride.

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous Tissue Disorders Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) (see WARNINGS, Severe Dermatologic Reactions ). To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 66 words ▾

Drug Interactions Concomitant administration of vancomycin hydrochloride and anesthetic agents has been associated with erythema and histamine-like flushing (see PRECAUTIONS, Pediatric Use ) and anaphylactoid reactions (see ADVERSE REACTIONS ) . Monitor renal function in patients receiving vancomycin hydrochloride and concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin, or cisplatin.

🤰 Pregnancy 147 words ▾

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with vancomycin hydrochloride. It is not known whether vancomycin hydrochloride can affect reproduction capacity. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse.

Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin hydrochloride was noted. One infant whose mother received vancomycin hydrochloride in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin hydrochloride.

Because the number of patients treated in this study was limited and vancomycin hydrochloride was administered only in the second and third trimesters, it is not known whether vancomycin hydrochloride causes fetal harm. Vancomycin hydrochloride should be given to a pregnant woman only if clearly needed.

🧓 Geriatric Use ~1 min read ▾

Geriatric Use The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin hydrochloride for injection dosage schedules should be adjusted in elderly patients (see DOSAGE AND ADMINISTRATION ). Information for Patients Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations.

Instruct patients to stop vancomycin hydrochloride for injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters (see WARNINGS ). Patients should be counseled that antibacterial drugs including vancomycin hydrochloride should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When vancomycin hydrochloride for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by vancomycin hydrochloride or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

🆘 Overdosage 100 words ▾

OVERDOSAGE Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice. To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR).

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Vancomycin hydrochloride is poorly absorbed after oral administration. In subjects with normal kidney function, multiple intravenous dosing of 1 gram of vancomycin hydrochloride (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion.

The plasma concentrations during multiple dosing are similar to those after a single dose. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin hydrochloride is excreted in urine by glomerular filtration.

Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days.

The distribution coefficient is from 0.3 to

0.43L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin hydrochloride administered during peritoneal dialysis is absorbed systemically in 6 hours.

Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin hydrochloride. However, the safety and efficacy of the intraperitoneal use of vancomycin hydrochloride has not been established in adequate and well-controlled trials (see PRECAUTIONS ). Total systemic and renal clearance of vancomycin may be reduced in the elderly.

Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After intravenous administration of vancomycin hydrochloride, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.

📦 How Supplied / Storage and Handling 104 words ▾

HOW SUPPLIED/STORAGE AND HANDLING Vancomycin Hydrochloride for Injection, USP is a white or off-white to light tan-colored powder or cake, and is available in a Pharmacy Bulk Package. It is supplied as follows: NDC Vancomycin Hydrochloride for Injection, USP Package Factor 71288- 025 -75 5 grams equivalent of vancomycin in a Pharmacy Bulk Package Bottle 1 bottle per carton 71288- 026 -75 10 grams equivalent of vancomycin in a Pharmacy Bulk Package Bottle 1 bottle per carton Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free.

Lyophilized. The container closure is not made with natural rubber latex.

📋 Description ~1 min read ▾

DESCRIPTION Vancomycin Hydrochloride for Injection, USP, is a white or off-white to light tan-colored lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 grams or 10 grams vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg per mL for the 5 gram Pharmacy Bulk Package bottle and 100 mg per mL for the 10 gram Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5.

This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION ), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE . Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis ).

The chemical name for vancomycin hydrochloride is [3 S -[3 R *,6 S *( S *),7 S *,22 S *,23 R *,26 R *,36 S *,38a S *]]-3-(2-Amino-2-oxoethyl)-44-[[2- O -(3-amino-2,3,6-trideoxy-3- C -methyl- α -L- lyxo -hexopyranosyl)-β-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]oxadiazacyclohexadecino[4,5- m ][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride.

The molecular formula is C 66 H 7 5 Cl 2 N 9 O 24 • HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package ).

FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION. structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Clinically significant serum concentrations have been reported in some patients being treated for active C. difficile -induced pseudomembranous colitis after multiple oral doses of vancomycin hydrochloride. Prolonged use of vancomycin hydrochloride may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential.

If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin hydrochloride. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.

Reversible neutropenia has been reported in patients receiving vancomycin hydrochloride (see ADVERSE REACTIONS ). Patients who will undergo prolonged therapy with vancomycin hydrochloride or those who are receiving concomitant drugs which may cause neutropenia should have periodic monitoring of the leukocyte count. Vancomycin hydrochloride for injection is irritating to tissue and must be given by a secure intravenous route of administration.

Pain, tenderness, and necrosis occur with intramuscular (IM) injection of vancomycin hydrochloride for injection or with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can be minimized by administering the drug slowly as a dilute solution (2.5 to 5 g/L) and by rotation of venous access sites. There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents.

Infusion-related events may be minimized by the administration of vancomycin hydrochloride as a 60-minute infusion prior to anesthetic induction. The safety and efficacy of vancomycin hydrochloride administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well controlled trials. Reports have revealed that administration of sterile vancomycin hydrochloride by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis.

To date, this syndrome has ranged from cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin hydrochloride. Prescribing vancomycin hydrochloride for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions Concomitant administration of vancomycin hydrochloride and anesthetic agents has been associated with erythema and histamine-like flushing (see PRECAUTIONS, Pediatric Use ) and anaphylactoid reactions (see ADVERSE REACTIONS ) . Monitor renal function in patients receiving vancomycin hydrochloride and concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin, or cisplatin.

Carcinogenesis, Mutagenesis, Impairment of Fertility Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of vancomycin hydrochloride was found in standard laboratory tests. No definitive fertility studies have been performed. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with vancomycin hydrochloride.

It is not known whether vancomycin hydrochloride can affect reproduction capacity. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnan… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 53 words ▾

Nursing Mothers Vancomycin is excreted in human milk. Caution should be exercised when vancomycin hydrochloride is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 37 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of vancomycin hydrochloride was found in standard laboratory tests. No definitive fertility studies have been performed.

📚 References 72 words ▾

REFERENCES Moellering RC, Krogstad DJ, Greenblatt DJ: Vancomycin therapy in patients with impaired renal function: A nomogram for dosage. Ann Inter Med 1981; 94:343. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2023 Meitheal Pharmaceuticals Inc.

Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Nanjing, China 210061 and Mfd. by Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 Revised: August 2023 8K4FBU9-01

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Container Label NDC 71288- 025 -75 Rx Only Vancomycin Hydrochloride for Injection, USP 5 grams* per Pharmacy Bulk Package PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION For Intravenous Infusion MUST BE FURTHER DILUTED BEFORE USE pdp-5g-vial pdp-5g-vial_kindos

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Carton NDC 71288- 025 -75 1 Pharmacy Bulk Package Bottle Rx Only Vancomycin Hydrochloride for Injection, USP 5 grams* per Pharmacy Bulk Package PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION For Intravenous Infusion MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT. pdp-5g-carton pdp-5g-carton_kindos

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Container Label NDC 71288- 026 -75 Rx Only Vancomycin Hydrochloride for Injection, USP 10 grams* per Pharmacy Bulk Package PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION For Intravenous Infusion MUST BE FURTHER DILUTED BEFORE USE pdp-10g-vial pdp-10g-vial_kindos

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Carton NDC 71288- 026 -75 1 Pharmacy Bulk Package Bottle Rx Only Vancomycin Hydrochloride for Injection, USP 10 grams* per Pharmacy Bulk Package PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION For Intravenous Infusion MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT. pdp-10g-carton pdp-10g-carton_kindos

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
226
Units reimbursed last 4 qtrs
362
Gross reimbursed last 4 qtrs
$21.1K
Avg / prescription
$93.50
Avg / unit
$58.3597
Latest quarter Q1 2026
28Rx
Fee-for-service vs managed care ⓘ
59% FFS 41% MCO
Fee-for-service · 133 Rx Managed care · 93 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 60 units · 0.5 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 132 units · 0.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 106 units · 1.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 63 units · 4.4 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.34.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 4.4 /100k
2 Arizona 1.4 /100k
3 Illinois 0.5 /100k
4 California 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Meitheal Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meitheal Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3373 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71288-0024-21 · Meitheal 71288-0026-75 · Meitheal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.