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Vancomycin 500 mg/100mL Injection, Solution — NDC 70594-0041-03 package photo

Vancomycin 500 mg/100mL Injection, Solution

by Xellia Pharmaceuticals USA LLC · 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01)
NDC 70594-0041-03
🏷️ FDA NDC (as labeled) 70594-041-03 billing pads the product segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$1.91 / unit · 12 mo Per package$2,297.16 / 1200 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 100 ml 70594-0041-02
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 70594-041-03
Product NDC 70594-041
11-digit billing NDC 70594004103
NCPDP billing unit ML — per mL (volume)
RxCUI 1807508, 1807510, 1807511, 2118448, 2118449, 2387078, 2387079
UNII 6Q205EH1VU
Application # NDA211962
SPL Set ID 60bee69b-be70-412c-9e83-a24a0a8a5e7b
Established class (EPC) Glycopeptide Antibacterial
Chemical class Glycopeptides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-15
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VANCOMYCIN
GPI-14 16280080102040
GPI class Vancomycin HCl
GCN Seq No 079533
GCN 46041
HICL code 045612
Ingredient (HICL) Vancomycin/Water For Inj (Peg)
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 500 MG/100 ML BAG
FDB brand name Vancomycin Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70594-041-03 — 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 → 70594-0041-03. 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.

🏭 Manufacturer & labeler

LabelerXellia Pharmaceuticals USA LLC
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationNDA211962 (NDA)
Labeler code70594
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio34 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.

🩺 Clinical

Label name VANCOMYCIN 500 MG/100 ML BAG Ingredient Vancomycin/Water For Inj (Peg)
📗 Our plain-language guide HelloPharmacist
  • It depends on what you're being treated for. If you have a serious infection like a bloodstream infection, heart valve infection, or bone infection, the oral form of vancomycin sim...
  • Why do I need an IV antibiotic — can't I just take a pill?
  • The two biggest things to watch for are changes in your hearing and changes in your urination. If you notice ringing in your ears, muffled hearing, or dizziness, let your doctor kn...
  • What should I watch out for while taking vancomycin?
📖 Read our full Vancomycin guide →
7
Nutrient depletion considerations

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

🧪 Full Vancomycin 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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 $1.91 $2,297.16 / 1200 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3375 $0.142 / J3375 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)70594-041-03
11-digit billing NDC70594-0041-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3375
Descriptor10 MG
Billing units / pkg600 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tyzavan 500 mg/100mL 00143-9471-06 Hikma 100 ml — — FDA listed —
Vancomycin Hydrochloride 500 mg/100mL 00338-3551-48 Baxter 100 ml — — FDA listed —
Vancomycin Hydrochloride 500 mg/100mL 00338-3581-01 Baxter 100 ml — — FDA listed —
Vancomycin 500 mg/100mLthis 70594-0041-03 Xellia 100 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2019
First FDA approval
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 15, 2019 RLD RS ⏳ ~9.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10188697 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10039804 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 11517609 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10188697 — method of use (U-282)
US 10039804 — method of use (U-282)
US 10849956 — drug product
US 12161690 — drug product
US 11628200 — drug product
US 10849956 — drug product
US 10849956 — drug product
US 11628200 — drug product
US 12161690 — drug product
US 11628200 — drug product
US 10849956 — drug product
US 11628200 — drug product
US 12161690 — drug product
US 10849956 — drug product
US 11628200 — drug product
US 12161690 — drug product
US 10849956 — drug product
US 11628200 — drug product
US 11628200 — drug product
US 10849956 — drug product
US 12161690 — drug product
US 12161690 — drug product
US 12161690 — drug product
2019 2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (42)
PatentTypeUse codeExpires
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 11517609 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10188697 ↗ Method of use U-282 Nov 6, 2035
US 10039804 ↗ Method of use U-282 Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 11628200 ↗ Drug product — Nov 6, 2035
US 10849956 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
US 12161690 ↗ Drug product — Nov 6, 2035
Common questions
Is there a generic version of VANCOMYCIN 500 MG/100 ML BAG?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VANCOMYCIN 500 MG/100 ML BAG. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🗺️ 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 70594-0041-03, 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 – Q4 2025 · 4 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
555
Units reimbursed last 4 qtrs
12.8K
Gross reimbursed last 4 qtrs
$24.6K
Avg / prescription
$44.30
Avg / unit
$1.9143
Latest quarter Q4 2025
136Rx
Fee-for-service vs managed care ⓘ
58% FFS 42% MCO
Fee-for-service · 322 Rx Managed care · 233 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: 67 units · 0.7 per 100k residents MI New York: 934 units · 4.8 per 100k residents 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: 74 units · 0.6 per 100k residents IL Indiana: 75 units · 1.1 per 100k residents IN Ohio: 242 units · 2.1 per 100k residents OH Pennsylvania: 38 units · 0.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 6,481 units · 92.6 per 100k residents MA California: 446 units · 1.1 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: 50 units · 0.6 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 109 units · 1.0 per 100k residents 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: 47 units · 0.4 per 100k residents GA D.C.: 4,000 units · 589 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 280 units · 1.2 per 100k residents FL
Units reimbursed · per 100k residents
0.3589
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 D.C. 589 /100k
2 Massachusetts 92.6 /100k
3 New York 4.8 /100k
4 Ohio 2.1 /100k
5 Florida 1.2 /100k
6 California 1.1 /100k
7 Indiana 1.1 /100k
8 North Carolina 1.0 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 ml this page70594-0041-03 555 Rx · $24,585
1 ml70594-0041-02 No Medicaid data
Drug total (last 4 qtrs): 555 Rx · 12,843 units · $24,585 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vancomycin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vancomycin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.3K
Claims incl. refills
26
Beneficiaries
12
Spend / beneficiary
$111.21
Spend / claim
$51.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Vancomycin — the ingredient across all brands.

Top reported reactions

Acute Kidney Injury4,892
Pyrexia4,046
Drug Reaction With Eosinophilia And Systemic Symptoms2,695
Renal Failure2,468
Diarrhoea2,392
Sepsis2,383
Pneumonia2,235

Reporter sex

65,520 reports
Male · 54%
Female · 45%
Unknown · 1%

Serious outcomes

Disabling1,408
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,337 2,096
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70594-0041-02 6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01) 2019-02-15 Active
70594-0041-03 You're viewing this 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01) 2019-02-15 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 70594-0041-03?
NDC 70594-0041-03 is listed by the FDA — 12 bag in 1 carton / 100 ml in 1 bag.
What NDC number is used to bill for this package of Vancomycin 500 mg/100mL Injection, Solution?
Bill NDC 70594-0041-03 — the 11-digit billing format is 70594004103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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?
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 182 words ▾

WARNING: POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin. This formulation of vancomycin injection contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which resulted in fetal malformations in animal reproduction studies at dose exposures approximately 8 and 32 times, respectively, higher than the exposures at the human equivalent dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .

WARNING: POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY See full prescribing information for complete boxed warning. If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin. This formulation of vancomycin injection contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which resulted in fetal malformations in animal reproduction studies at dose exposures approximately 8 and 32 times, respectively, higher than the exposures at the human equivalent dose ( 5.1 , 8.1 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

( 1.6 )

1.1Septicemia Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.2Infective Endocarditis Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Injection in combination with an aminoglycoside.

Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside.

1.3Skin and Skin Structure Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of skin and skin structure infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.4Bone Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of bone infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.5Lower Respiratory Tract Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of lower respiratory tract infections due to: Susceptible isolates of MRSA Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

1.6Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin 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.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof. ( 2.1 ) For intravenous use only. Do Not administer orally.

Administer Vancomycin Injection by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions ( 2.1 ) Adult Patients: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours ( 2.2 ) Pediatric Patients (1 Month and Older): 10 mg/kg per dose given every 6 hours ( 2.3 ) Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment ( 2.4 ) See full prescribing information for further important administration and preparation instructions ( 2.1 , 2.5 )

2.1Important Administration Instructions Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Vancomycin Injection [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ]. Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof. Vancomycin Injection in transparent single-dose flexible bags are intended for intravenous use only.

Do NOT administer orally. To reduce the risk of infusion related adverse reactions, administer Vancomycin Injection by intravenous infusion over 60 minutes or greater [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . An infusion rate of 10 mg/min or less is associated with fewer infusion-related events [see Warnings and Precautions (5.2) ] .

Infusion related events may occur, however, at any rate or concentration. Drug additives should not be made to this solution. Vancomycin Injection concentrations of no more than 5 mg/mL are recommended in adults [see Dosage and Administration (2.2) ] .

See also age-specific recommendations [see Dosage and Administration (2.3) ] . Administer Vancomycin Injection prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions (5.2) ] . Administer Vancomycin Injection by a secure intravenous route of administration to avoid local irritation and phlebitis reactions [see Warnings and Precautions (5.9) ] .

2.2Dosage in Adult Patients with Normal Renal Function The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. The initial daily dose should be no less than 15 mg/kg.

2.3Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function Use this formulation of Vancomycin Injection only in pediatric patients (1 month and older) who require the entire dose (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) of this single-dose flexible bag and not any fraction of it [see Dosage Forms and Strengths (3) ]. The usual intravenous dosage of vancomycin 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.

2.4Dosage in Patients with Renal Impairment Dosage adjustment must be made in patients with renal impairment. The initial dose should be no less than 15 mg/kg in patients with any degree of renal impairment. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function.

Measure trough vancomycin serum concentrations to guide therapy, especially in seriously ill patients with changing renal function. For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentration. A dose of 1.9 mg/kg/24 h should…

💊 Dosage Forms and Strengths 138 words ▾

3 DOSAGE FORMS AND STRENGTHS Vancomycin Injection, USP is a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg vancomycin in 100 mL, 750 mg vancomycin in 150 mL, 1 g vancomycin in 200 mL, 1.25 g vancomycin in 250 mL, 1.5 g vancomycin in 300 mL, 1.75 g vancomycin in 350 mL and 2 g vancomycin in 400 mL of liquid [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. Vancomycin Injection, USP: Single-dose flexible bags containing 500 mg vancomycin in 100 mL, 750 mg vancomycin in 150 mL, 1 g vancomycin in 200 mL, 1.25 g vancomycin in 250 mL, 1.5 g vancomycin in 300 mL, 1.75 g vancomycin in 350 mL and 2 g vancomycin in 400 mL of liquid.

( 3 )

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS Vancomycin Injection is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Infusion Reactions : Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and "red man syndrome" which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1 , 5.2 ) Nephrotoxicity : Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis.

Monitor serum vancomycin concentrations and renal function. ( 5.3 ) Ototoxicity : Ototoxicity has occurred in patients receiving vancomycin. Monitor for signs and symptoms of ototoxicity during therapy.

Monitor serum vancomycin concentrations and renal function. Assessment of auditory function may be appropriate in some instances. ( 5.4 ) Severe Dermatologic Reactions : Discontinue Vancomycin Injection at the first appearance of skin rashes, mucosal lesions, or blisters.

( 5.5 ) Clostridioides difficile -Associated Diarrhea : Evaluate patients if diarrhea occurs. ( 5.6 ). Neutropenia : Periodically monitor leukocyte count.

( 5.8 ) Phlebitis : To reduce the risk of local irritation and phlebitis administer Vancomycin Injection by a secure intravenous route of administration. ( 5.9 ) Development of Drug-Resistant Bacteria : Prescribing Vancomycin Injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. ( 5.10 )

5.1Potential Risk of Exposure to Excipients During the First or Second Trimester of Pregnancy If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin. This formulation of Vancomycin Injection contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA). In a rabbit reproduction study, fetal spinal malformations occurred when the excipient PEG 400 was administered at dose exposures approximately 8 times the exposure at the maximum daily human dose.

In a separate rabbit reproduction study, fetal spinal and cardiovascular malformations occurred when the excipient NADA was administered at dose exposures approximately 32 times the exposure at the maximum daily human dose. The active ingredient vancomycin is not known to be associated with embryo-fetal toxicity [ see Use in Specific Populations (8.1) ] .

5.2Infusion Reactions Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain may occur with rapid Vancomycin Injection administration. The reactions may be more severe in younger patients, particularly children, and in patients receiving concomitant muscle relaxant anesthetics. Rapid intravenous administration of Vancomycin Injection may also be associated with "red man syndrome", which manifests as pruritus and erythema that involves the face, neck and upper torso.

Infusion-related adverse reactions are related to both the concentration and the rate of administration of vancomycin. Infusion-related adverse reactions may occur, however, at any rate or concentration. Administer Vancomycin Injection over a period of 60 minutes or greater to reduce the risk of infusion-related adverse reactions.

In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related adverse reactions. Administer prior to intravenous anesthetic agents when feasible. Stop the infusion if a reaction occurs.

5.3Nephrotoxicity Vancomycin Injection can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifes…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.2) ] Nephrotoxicity [see Warnings and Precautions (5.3) ] Ototoxicity [see Warnings and Precautions (5.4) ] Severe Dermatologic Reactions [see Warnings and Precautions (5.5) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.6) ] Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.7) ] Neutropenia [see Warnings and Precautions (5.8) ] The common adverse reactions are anaphylaxis, "red man syndrome", acute kidney injury, hearing loss, neutropenia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions associated with the use of vancomycin were identified in clinical trials: Immune System Disorders: Hypersensitivity reactions including anaphylaxis and "red man syndrome" [see Warnings and Precautions (5.2) ] Skin and Subcutaneous Tissue Disorders: Erythema (especially of the face, neck and upper torso) and pruritus which are manifestations of rashes including exfoliative dermatitis.

Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), Linear IgA bullous dermatosis (LABD) [see Warnings and Precautions (5.5) ] . Renal and Urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Tinnitus, hearing loss, vertigo Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia Gastrointestinal Disorders: Pseudomembranous colitis [see Warnings and Precautions (5.6) ] Cardiac Disorders: Cardiac arrest, chest pain General Disorders and Administration Site Conditions: General discomfort, fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin Injection is not approved for intramuscular and intraperitoneal administration) [see Warnings and Precautions (5.9) ] Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine Musculoskeletal and Connective Tissue Disorders: Muscle pain Nervous System Disorders: Dizziness Respiratory, Thoracic and Mediastinal Disorders: Wheezing, dyspnea Vascular Disorders: Hypotension, shock, vasculitis

6.2Post Marketing Experience The following adverse reactions have been identified during postmarketing use of vancomycin. 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: Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) [see Warnings and Precautions (5.5) ] .

🔄 Drug Interactions 155 words ▾

7 DRUG INTERACTIONS Anesthetic Agents : Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. ( 2.1 , 7.1 ) Piperacillin/Tazobactam : Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients. ( 7.2 )

7.1Anesthetic Agents Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ] .

7.2Piperacillin-Tazobactam Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and vancomycin. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin.

7.3Ototoxic and/or Nephrotoxic Drugs Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs requires more frequent monitoring of renal function.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary This formulation of Vancomycin Injection is not recommended for use during the first or second trimester of pregnancy because it contains the excipients, PEG 400 and NADA, which caused fetal malformations in animal reproduction studies (see Data ) . Advise pregnant women of the potential risk to the fetus. If therapy with Vancomycin Injection is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin, free of PEG 400 and NADA.

The available data on use of this formulation of Vancomycin Injection (with the excipients PEG 400 and NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available published data on vancomycin (without the excipients PEG 400 and NADA) use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ) . There are no available data on first trimester use of vancomycin in pregnant women to assess the risk of major birth defects or miscarriage.

Vancomycin alone did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data ) . Reproduction studies in rabbits with intravenous doses of PEG 400 at approximately 8 times the maximum daily human dose based on systemic exposures of PEG 400 during organogenesis resulted in fetal spinal malformations. Reproduction studies in rabbits and rats using intravenous doses of NADA at approximately 32 and 20 times the maximum daily human dose, respectively, based on systemic exposures of NADA resulted in maternal toxicity and fetal spinal and cardiovascular malformations in rabbits, and maternal toxicity with no adverse embryo-fetal effects in rats.

Vancomycin alone did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Human Data Available data from postmarketing cases on use of this formulation of vancomycin injection (with the excipients PEG 400 and NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or infant outcomes. There are no available data on first trimester use of vancomycin (without the excipients PEG 400 and NADA); however, available published data on use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes.

A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with vancomycin (formulation did not include the excipients PEG 400 and NADA) for suspected or documented methicillin-resistant Staphylococcus aureus in the second or third trimester. The comparison groups were 10 uninfected non-intravenous drug-dependent patients, and 10 uninfected intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin (formulation did not include the excipients PEG 400 and NADA) at the time of delivery. Vancomyc…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary This formulation of Vancomycin Injection is not recommended for use during the first or second trimester of pregnancy because it contains the excipients, PEG 400 and NADA, which caused fetal malformations in animal reproduction studies (see Data ) . Advise pregnant women of the potential risk to the fetus. If therapy with Vancomycin Injection is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin, free of PEG 400 and NADA.

The available data on use of this formulation of Vancomycin Injection (with the excipients PEG 400 and NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available published data on vancomycin (without the excipients PEG 400 and NADA) use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ) . There are no available data on first trimester use of vancomycin in pregnant women to assess the risk of major birth defects or miscarriage.

Vancomycin alone did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data ) . Reproduction studies in rabbits with intravenous doses of PEG 400 at approximately 8 times the maximum daily human dose based on systemic exposures of PEG 400 during organogenesis resulted in fetal spinal malformations. Reproduction studies in rabbits and rats using intravenous doses of NADA at approximately 32 and 20 times the maximum daily human dose, respectively, based on systemic exposures of NADA resulted in maternal toxicity and fetal spinal and cardiovascular malformations in rabbits, and maternal toxicity with no adverse embryo-fetal effects in rats.

Vancomycin alone did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Human Data Available data from postmarketing cases on use of this formulation of vancomycin injection (with the excipients PEG 400 and NADA) in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or infant outcomes. There are no available data on first trimester use of vancomycin (without the excipients PEG 400 and NADA); however, available published data on use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes.

A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with vancomycin (formulation did not include the excipients PEG 400 and NADA) for suspected or documented methicillin-resistant Staphylococcus aureus in the second or third trimester. The comparison groups were 10 uninfected non-intravenous drug-dependent patients, and 10 uninfected intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin (formulation did not include the excipients PEG 400 and NADA) at the time of delivery. Vancomycin dosing ranged from the stan…

🧒 Pediatric Use 98 words ▾

8.4Pediatric Use Vancomycin Injection is indicated in pediatric patients (1 month and older) [see Indications and Usage (1.1 to 1.5) and Dosage and Administration (2.2) ]. In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Injection [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . More severe infusion related reactions related to vancomycin administration may occur in pediatric patients.

Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions (5.2) ] .

🧓 Geriatric Use 72 words ▾

8.5Geriatric Use Vancomycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see Dosage and Administration (2.2) ] , and it may be useful to monitor renal function [see Warnings and Precautions (5.2) ] .

🆘 Overdosage 50 words ▾

10 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. For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology (12.4) ] .

12.2Pharmacodynamics The pharmacodynamics of vancomycin is unknown.

12.3Pharmacokinetics In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (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 like those after a single dose. In healthy subjects administered a single 1g dose of Vancomycin Injection, geometric mean (geometric %CV) AUC 0-inf values for NADA, PEG 400, and vancomycin were 209 (19.6%), 405 (12.5%), and 219 (13.7%) mcg*h/mL, respectively. Based on a population pharmacokinetic analysis, 1g Vancomycin Injection administered over 1.5 hours every 12 hours achieves a geometric mean (95% prediction interval) steady state AUC 0-24 exposure of 384 (277-547) , 734 (550-994), and 384 (261-567) mcg*h/mL for NADA, PEG 400, and vancomycin in healthy subjects, respectively.

Distribution The volume of distribution ranges from 0.3 to

0.43L/kg after intravenous administration. 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, 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. Elimination Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function.

In anephric patients, the mean elimination half-life is 7.5 days. Total body and renal clearance of vancomycin may be reduced in the elderly. Metabolism There is no apparent metabolism of the vancomycin.

Excretion In the first 24 hours after intravenous administration, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Renal impairment slows excretion of vancomycin. In the first 48 hours after intravenous administration of a single 1 g dose of Vancomycin Injection, the percent excreted unchanged in urine was approximately 80% and 50% for NADA and PEG 400, respectively.

12.4Microbiology Mechanism of Action The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. Resistance Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

There is no cross-resistance between vancomycin and other antibacterials. Interaction with Other Antimicrobials The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many isolates of Staphylococcus aureus , Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus spp, and the viridans group streptococci. Antimicrobial Activity Vancomycin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections [see Indications and Usage (1) ] .

Aerobic Gram-Positive Bacteria Corynebacterium spp. Enterococcu s spp. (including Enterococcus faecalis ) Staphylococcus aureus (i…

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Vancomycin is an antibacterial drug [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 202 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Vancomycin Injection, USP is supplied as a ready to use clear, colorless to light brown solution in single-dose flexible bags containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g vancomycin in 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL and 400 mL of liquid (consists of water and PEG together with the excipients NADA and lysine) [see Description (11) ] . The flexible bags are supplied in sealed aluminum overpouches. The bags are supplied in the following packages:

16.2Storage NDC number Packaging configuration 70594-041-02 Carton of six 500 mg/100 mL bags 70594-041-03 Carton of twelve 500 mg/100 mL bags 70594-056-02 Carton of six 750 mg/150 mL bags 70594-056-03 Carton of twelve 750 mg/150 mL bags 70594-042-02 Carton of six 1 g/200 mL bags 70594-042-03 Carton of twelve 1 g/200 mL bags 70594-057-02 Carton of six 1.25 g/250 mL bags 70594-043-02 Carton of six 1.5 g/300 mL bags 70594-058-02 Carton of six 1.75 g/350 mL bags 70594-044-02 Carton of six 2 g/400 mL bags Store below 25°C (77ºF), in original package.

Product should be used within 28 days of removal from aluminum overpouch.

📦 Storage and Handling 105 words ▾

16.2Storage NDC number Packaging configuration 70594-041-02 Carton of six 500 mg/100 mL bags 70594-041-03 Carton of twelve 500 mg/100 mL bags 70594-056-02 Carton of six 750 mg/150 mL bags 70594-056-03 Carton of twelve 750 mg/150 mL bags 70594-042-02 Carton of six 1 g/200 mL bags 70594-042-03 Carton of twelve 1 g/200 mL bags 70594-057-02 Carton of six 1.25 g/250 mL bags 70594-043-02 Carton of six 1.5 g/300 mL bags 70594-058-02 Carton of six 1.75 g/350 mL bags 70594-044-02 Carton of six 2 g/400 mL bags Store below 25°C (77ºF), in original package.

Product should be used within 28 days of removal from aluminum overpouch.

📋 Description 161 words ▾

11 DESCRIPTION Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). The molecular formula is C 66 H 75 Cl 2 N 9 O 24 ∙HCl and the molecular weight is 1,485.71.

The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-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-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride.

Vancomycin hydrochloride has the following structural formula: Vancomycin Injection, USP, in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment.

The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Potential Risk of Exposure to Excipients During the First or Second Trimester of Pregnancy Advise patients to notify their healthcare provider if they are pregnant prior to treatment with this formulation of vancomycin [see Boxed Warning , Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Infusion Reactions During or After Intravenous Use Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during Vancomycin Injection infusion.

These reactions can be lessened or prevented by infusing the drug over at least 60 minutes [see Warnings and Precautions (5.2) ] . Acute Kidney Injury Advise patients that Vancomycin Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions (5.3) ] . Hearing Loss or Balance Problems Advise patients that Vancomycin Injection may result in decreased hearing and to report hearing loss or balance problems to their health care provider [see Warnings and Precautions (5.4) ] .

Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions or blisters to their healthcare provider [see Warnings and Precautions (5.5) ] . Diarrhea Diarrhea is a common problem caused by antibacterial drugs, including vancomycin, which usually ends when the antibacterial drug is discontinued.

Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.2) ] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including vancomycin, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When vancomycin 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 or other antibacterial drugs in the future.

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