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TYZAVAN Vancomycin 750 mg/150mL Injection, Solution — NDC 00143-9468-06 package photo

TYZAVAN Vancomycin 750 mg/150mL Injection, Solution

by Hikma Pharmaceuticals USA Inc. · 6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01)
NDC 00143-9468-06
🏷️ FDA NDC (as labeled) 0143-9468-06 billing pads the labeler segment with a zero
This package
Contains150 mL in 1 bag Pack sizes2 compare ↓
Also priced by: Part D plans $0.0940/unit — full pricing hub ↓
Also comes in: 150 ml 00143-9468-12
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 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) 0143-9468-06
Product NDC 0143-9468
11-digit billing NDC 00143946806
RxCUI 1807508, 1807510, 1807511, 2118448, 2118449, 2387078, 2387079, 2725135,
UNII 6Q205EH1VU
Application # NDA211962
SPL Set ID 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560
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 2025-10-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VANCOMYCIN
GCN Seq No 088436
GCN 58565
HICL code 050959
Ingredient (HICL) Vancomycin/Water For Inj(Nada)
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 TYZAVAN 750 MG/150 ML BAG
FDB brand name Tyzavan
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0143-9468-06 — a 4-4-2 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 labeler segment → 00143-9468-06. 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationNDA211962 (NDA)
Labeler code00143
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio726 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 TYZAVAN 750 MG/150 ML BAG Ingredient Vancomycin/Water For Inj(Nada)
📖 What it is MedlinePlus · NLM

Vancomycin injection is used to treat certain serious infections caused by bacteria. Vancomycin injection is in a class of medications called glycopeptide antibiotics. It works by killing bacteria that cause infections. Antibiotics such as vancomycin injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII JNJ23Q2COM
    Lysine hydrochloride is an amino acid salt used in medicines as a buffer and pH stabilizer. It helps maintain the acidity level of the product to keep the active ingredient stable and effective.
  • UNII IIE41SBQ9L
    N-acetyl-D-alanine is an amino acid derivative, a modified form of the amino acid alanine. It's used in medicines as a buffering agent to help maintain the pH balance and stability of the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0940 $84.60 / 900 ml
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)0143-9468-06
11-digit billing NDC00143-9468-06
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ3375
DescriptorINJECTION, VANCOMYCIN HYDROCHLORIDE (XELLIA), NOT THERAPEUTICALLY EQUIVALENT TO J3373, 10 MG
Billing units / pkg0.5 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tyzavan 750 mg/150mLthis 00143-9468-06 Hikma 150 ml — — FDA listed —
Vancomycin Hydrochloride 750 mg/150mL 00338-3580-48 Baxter 200 ml — — FDA listed —
Vancomycin Hydrochloride 750 mg/150mL 00338-3582-01 Baxter 150 ml — — FDA listed —
Vancomycin 750 mg/150mL 70594-0056-02 Xellia 150 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 TYZAVAN 750 MG/150 ML BAG?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TYZAVAN 750 MG/150 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.

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

Medicare Part D (outpatient prescription) spending for Tyzavan — 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 Tyzavan. 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.
Total Part D spend
$78.7K
Claims incl. refills
859
Beneficiaries
390
Spend / beneficiary
$201.83
Spend / claim
$91.64
💵 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

Age at onset

Neonate412
Infant290
Child601
Adolescent347
Adult4,320
Elderly2,570

Reporter sex

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

Serious outcomes

Hospitalization34,799
Death12,906
Life-threatening9,326
Disabling1,408
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,337 0
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
00143-9468-06 You're viewing this 6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) 2025-10-17 Active
00143-9468-12 12 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) 2025-10-17 Active

Pack size FAQ

What quantity is in NDC 00143-9468-06?
NDC 00143-9468-06 is listed by the FDA — 6 bag in 1 carton / 150 ml in 1 bag.
What NDC number is used to bill for this package of TYZAVAN Vancomycin 750 mg/150mL Injection, Solution?
Bill NDC 00143-9468-06 — the 11-digit billing format is 00143946806. 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) ✓ 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 0143-9468-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00143-9468-06, written without dashes as 00143946806. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00143-9468-06, the first segment (00143) is the labeler code FDA assigned to Hikma Pharmaceuticals USA Inc.; the middle segment (9468) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 150 ml (00143-9468-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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 J3375 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.

📄 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.
🎯 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
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: 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 TYZAVAN and other antibacterial drugs, TYZAVAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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1.1Septicemia TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 TYZAVAN 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. TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 TYZAVAN is indicated in adults and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4) ] 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 c…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. ( 2.1 ). For intravenous use only.

Do not administer orally ( 2.1 ). Administer TYZAVAN by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions ( 2.1 ) Recommended Dosage in Adult Patients with Normal Renal Function: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours ( 2.2 ) Recommended Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function: 10 mg/kg per dose given every 6 hours ( 2.3 ) Recommended Dosage in 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 preparation and administration instructions ( 2.1, 2.5 )

2.1Important Administration Instructions If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered. TYZAVAN is intended for intravenous use only. TYZAVAN is not to be administered orally.

To reduce the risk of infusion related adverse reactions, administer TYZAVAN by intravenous infusion over 60 minutes or greater [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . An infusion rate of 10 mg/min or less is associated with fewer infusion-related adverse reactions [see Warnings and Precautions (5.1) ] . Infusion related adverse reactions may occur, however, at any rate or concentration.

Drug additives should not be made to this solution. TYZAVAN concentrations of no more than 5 mg/mL are recommended in adults and pediatric patients (1 month and older) [see Dosage and Administration (2.2) ] . See also age-specific recommendations [see Dosage and Administration (2.3) ] .

Administer TYZAVAN by a secure intravenous route of administration to reduce the risk of local irritation and phlebitis reactions [see Warnings and Precautions (5.8) ] . Administer TYZAVAN prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions (5.1) ] .

2.2Recommended Dosage in Adult Patients with Normal Renal Function The usual daily intravenous dosage of TYZAVAN is 2 grams (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.

2.3Recommended Dosage in Pediatric Patients (1 Month and Older) with Normal Renal Function If a dose of TYZAVAN is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered [see Use in Specific Populations (8.4) ] . Pediatric Patients (Aged 1 Month and Older) The usual intravenous dosage of TYZAVAN 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.

2.4Recommended Dosage in Adult Patients with Renal Impairment Dosage adjustment must be made in adult patients with renal impairment. The initial dose of TYZAVAN 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 t…

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: TYZAVAN (Vancomycin Injection, USP) is a ready to use clear, colorless to light brown sterile solution in single-dose flexible bags in the following strengths: 500 mg vancomycin in 100 mL (5 mg/mL), 750 mg vancomycin in 150 mL (5 mg/mL), 1 g vancomycin in 200 mL (5 mg/mL), 1.25 g vancomycin in 250 mL (5 mg/mL), 1.5 g vancomycin in 300 mL (5 mg/mL), 1.75 g vancomycin in 350 mL (5 mg/mL) and 2 g vancomycin in 400 mL (5mg/mL) of Water for Injection [see Description (11) ] . Injection: TYZAVAN contains 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 (5 mg/mL) of Water for Injection in single-dose flexible bags.

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⛔ Contraindications 18 words ▾

4 CONTRAINDICATIONS TYZAVAN 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 “vancomycin infusion reactions” which manifests as pruritus and erythema that involves the face, neck and upper body may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer TYZAVAN over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. ( 2.1, 5.1 ) Nephrotoxicity : Monitor renal function in all patients receiving TYZAVAN.

( 5.2 ) Ototoxicity : Serial tests of auditory function may be helpful. ( 5.3 ) Severe Dermatologic Reactions : Discontinue TYZAVAN at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. ( 5.4 ) Clostridioides difficile -Associated Diarrhea (CDAD) : Evaluate patients if diarrhea occurs.

( 5.5 ). Neutropenia : Periodically monitor leukocyte count. ( 5.7 ) Phlebitis and Other Administration Site Reactions : Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration.

( 5.8 )

5.1Infusion Reactions Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria or pruritus, muscular and chest pain may occur with rapid TYZAVAN administration (e.g., over several minutes). The reactions may be more severe in pediatric patients (1 month and older) [see Use in Specific Populations (8.4) ] . Rapid intravenous administration of TYZAVAN may also be associated with “vancomycin infusion reactions” which manifests as pruritus and erythema that involves the face, neck and upper body or pain and muscle spasm of the chest and back.

There have been reports that the frequency of of infusion-related reactions (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related adverse reactions are related to both the concentration and the rate of administration of TYZAVAN. Infusion-related adverse reactions may occur, however, at any rate or concentration.

Administer TYZAVAN 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 TYZAVAN as a 60-minute infusion prior to administration of intravenous anesthetic agents when feasible to minimize infusion-related adverse reactions.

Stop the infusion if a reaction occurs because this usually results in prompt cessation of these reactions.

5.2Nephrotoxicity TYZAVAN can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions (7.2) ] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment.

Monitor serum vancomycin concentrations and renal function in all patients receiving TYZAVAN. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels. If acute kidney injury occurs, discontinue TYZAVAN or reduce the dose [see Dosage and Administration (2.4) ] .

5.3Ototoxicity Ototoxicity has occurred in patients receiving vancomycin. It may be reversible or permanent. Ototoxicity manifests as tinnitus, hearing loss, dizziness or vertigo. The…

🤒 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 (5.1) ] Nephrotoxicity [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] Severe Dermatologic Reactions [see Warnings and Precautions (5.4) ] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.6) ] Neutropenia [see Warnings and Precautions (5.7) ] Phlebitis and Other Administration Site Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions are anaphylaxis, “vancomycin infusion reactions”, acute kidney injury, hearing loss, neutropenia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 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: Anaphylaxis and “vancomycin infusion reaction” Renal and Urinary Disorders: Acute kidney injury and interstitial nephritis Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus Skin and Subcutaneous Tissue Disorders: Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS) Gastrointestinal Disorders: Clostridioides difficile colitis, nausea Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia 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 (TYZAVAN is not approved for intramuscular and intraperitoneal administration) 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

6.2Postmarketing 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. Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.

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). Blood and Lymphatic System Disorders: Hemolytic anemia

🔄 Drug Interactions 157 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 (5.1) 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 TYZAVAN. 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 with TYZAVAN requires more frequent monitoring of renal function.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available data on the use of this formulation of TYZAVAN (which includes the excipient 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 (see Data ) . Available data over several decades of vancomycin (without the excipient NADA) use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) .

Vancomycin 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 (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 excipient 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 excipient 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 intravenously administered vancomycin (formulation did not include the excipient NADA) for suspected or documented methicillin-resistant Staphylococcus aureus (MRSA) in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated 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 excipient NADA) at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns.

None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at doses less than or equal to the recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits.

No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). 1 Animal reproduction studies conducted in pregnant rabbits (gestation days 6 to 19) administered intravenous NADA at 1680 mg/kg (32 times the maximum daily human dose or greater based on AUC levels of NADA) resulted in fetal scoliosis and a spectrum of cardiovascular malformations.

Increased incidence of de…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary The available data on the use of this formulation of TYZAVAN (which includes the excipient 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 (see Data ) . Available data over several decades of vancomycin (without the excipient NADA) use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) .

Vancomycin 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 (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 excipient 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 excipient 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 intravenously administered vancomycin (formulation did not include the excipient NADA) for suspected or documented methicillin-resistant Staphylococcus aureus (MRSA) in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated 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 excipient NADA) at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns.

None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at doses less than or equal to the recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits.

No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). 1 Animal reproduction studies conducted in pregnant rabbits (gestation days 6 to 19) administered intravenous NADA at 1680 mg/kg (32 times the maximum daily human dose or greater based on AUC levels of NADA) resulted in fetal scoliosis and a spectrum of cardiovascular malformations.

Increased incidence of delayed or incomplete ossificati…

🧒 Pediatric Use 201 words ▾

8.4Pediatric Use TYZAVAN is indicated in pediatric patients (1 month and older) for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1 to 1.5) and Dosage and Administration (2.1, 2.3) ] . Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of TYZAVAN, and to avoid unintentional overdose, this product is not recommended for use if a dose of TYZAVAN that does not equal 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g and 2 g is required, and an alternative formulation of vancomycin should be considered [see Dosage and Administration (2.1, 2.3) ] .

More severe infusion related reactions related to vancomycin administration may occur in pediatric patients. In pediatric patients, monitor vancomycin serum concentration and renal function when administering TYZAVAN [see Dosage and Administration ( 2.3) and Warnings and Precautions (5.1) ]. 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 (5.1) ] .

🧓 Geriatric Use 72 words ▾

8.5Geriatric Use TYZAVAN 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 (2.4) ] , 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 Based on animal models of infection, the antimicrobial activity of vancomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including methicillin resistant Staphylococcus aureus. The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials 2,3 .

12.3Pharmacokinetics General Pharmacokinetics 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 similar those after a single dose. In healthy subjects administered a single 1g dose of TYZAVAN, geometric mean (geometric %CV) AUC 0-inf values for NADA and vancomycin were 209 (19.6%) and 219 (13.7%) mcg*h/mL, respectively. Based on a population pharmacokinetic analysis, 1g TYZAVAN administered over 1.5 hours every 12 hours achieves a geometric mean (95% prediction interval) steady state AUC 0-24 exposure of 383 (277-547) and 382 (261-567) mcg*h/mL for NADA and vancomycin in healthy subjects, respectively.

Distribution The distribution coefficient is from 0.3 to

0.43L/kg. 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 systemic 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, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Renal dysfunction slows excretion of vancomycin. In the first 48 hours after intravenous administration of a single 1 g dose of TYZAVAN, the percent excreted unchanged in urine was approximately 80% for NADA.

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 There is no cross-resistance between vancomycin and other antibacterial(s).

Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi. 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…

🧬 Mechanism of Action 14 words ▾

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

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TYZAVAN (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 for injection 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 described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags

16.2Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch.

16.1How Supplied TYZAVAN (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 for injection 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 described in table 1 below: Table 1: TYZAVAN PACKAGE INFORMATION Strength of TYZAVAN NDC number Packaging configuration 500 mg/100 mL (5 mg/mL) 0143-9471-06 Carton of 6 bags 500 mg/100 mL (5 mg/mL) 0143-9471-12 Carton of 12 bags 750 mg/150 mL (5 mg/mL) 0143-9468-06 Carton of 6 bags 750 mg/150 mL (5 mg/mL) 0143-9468-12 Carton of 12 bags 1 g/200 mL (5 mg/mL) 0143-9472-06 Carton of 6 bags 1 g/200 mL (5 mg/mL) 0143-9472-12 Carton of 12 bags 1.25 g/250 mL (5 mg/mL) 0143-9466-06 Carton of 6 bags 1.5 g/300 mL (5 mg/mL) 0143-9469-06 Carton of 6 bags 1.75 g/350 mL (5 mg/mL) 0143-9467-06 Carton of 6 bags 2 g/400 mL (5 mg/mL) 0143-9470-06 Carton of 6 bags

📦 Storage and Handling 22 words ▾

16.2Storage Store at 15°C to 25°C (59°F to 77ºF), in original package. Use within 28 days of removal from aluminum overpouch.

📋 Description 191 words ▾

11 DESCRIPTION TYZAVAN (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 chemical name is ( S a )-(3 S ,6 R ,7 R ,22 R ,23 S ,26 S ,36 R ,38a R )-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-[(2 R )-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride.

The molecular formula is C 66 H 75 Cl 2 N 9 O 24 •HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula: TYZAVAN (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 1.36 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. Structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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 intravenous infusion of TYZAVAN. These reactions can be lessened or prevented by infusing the drug over at least 60 minutes [see Warnings and Precautions (5.1) ] . Acute Kidney Injury Advise patients that TYZAVAN 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 (5.2) ] .

Hearing Loss or Balance Problems Advise patients that TYZAVAN may result in decreased hearing and to report hearing loss or balance problems to their healthcare provider [see Warnings and Precautions (5.3) ] . Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop TYZAVAN immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters to their healthcare provider [see Warnings and Precautions (5.4) ] .

Diarrhea Diarrhea is a common problem caused by antibacterial drugs, including TYZAVAN, 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 (5.5) ] .

Antibacterial Resistance Patients should be counseled that antibacterial drugs including TYZAVAN, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYZAVAN 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 TYZAVAN or other antibacterial drugs in the future. Manufactured for: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Made in Switzerland L130USTZV03 Hikma logo

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.