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FIRVANQ vancomycin hydrochloride Kit — NDC 65628-0205-10 package photo

FIRVANQ vancomycin hydrochloride Kit

by Azurity Pharmaceuticals, Inc · 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE
NDC 65628-0205-10
🏷️ FDA NDC (as labeled) 65628-205-10 billing pads the product segment with a zero
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

⚠️
Other active recalls for Vancomycin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0820-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0805-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class I · Aug 24, 2021 · Terminated — Product Mix-up: Incorrect diluent component included in the kit. (Azurity Pharmaceuticals, Inc.) · FDA recall D-0003-2022

🆔 Identity & classification

FDA NDC (as labeled) 65628-205-10
Product NDC 65628-205
11-digit billing NDC 65628020510
NCPDP billing unit ML — per mL (volume)
RxCUI 2000127, 2000133, 2000134, 2000136
Application # NDA208910
SPL Set ID 5aca5508-b577-446c-9980-ab4c7582b4b9
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-26
Dosage form KIT
GPI-14 16280080102160
GCN Seq No 078128
GCN 44411
HICL code 004042
Ingredient (HICL) Vancomycin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1J
Therapeutic class — specific (HIC3) Vancomycin Antibiotics And Derivatives
AHFS code 08:12.28.16
AHFS class Glycopeptide Antibiotics
FDB label name FIRVANQ 25 MG/ML SOLUTION
FDB brand name Firvanq
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 65628-205-10 — 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 → 65628-0205-10. 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

LabelerAzurity Pharmaceuticals, Inc
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA208910 (NDA)
Labeler code65628
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio4 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 FIRVANQ 25 MG/ML SOLUTION Ingredient Vancomycin Hcl
📗 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 Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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

💊 What it looks like

FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

💲 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 $0.471 —
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 $0.9630 —
NADAC price history (per mL) — tap or hover for the price & month
Jul 2021 $0.471 $0.471
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vancomycin Hydrochloride for Oral Solution 52536-0107-10 Wilshire 1 kit $0.390 AA Availability likely save 17%
Vancomycin Hydrochloride 67877-0750-58 Ascend 1 kit $0.390 AA Availability likely save 17%
Firvanqthis 65628-0205-10 Azurity 1 kit $0.471 AA FDA listed —
Vancomycin Hydrochloride for Oral Solution 52536-0104-05 Wilshire 1 kit $0.673 AA Availability likely +43%
Vancomycin Hydrochloride for Oral Solution 52536-0106-05 Wilshire 1 kit $0.702 AA Availability likely +49%
Vancomycin Hydrochloride 67877-0751-58 Ascend 1 kit $0.801 AA Availability likely +70%
Vancomycin Hydrochloride for Oral Solution 52536-0108-10 Wilshire 1 kit $0.801 AA Availability likely +70%
Firvanq 65628-0206-05 Azurity 1 kit $1.186 AA Availability likely +152%
Firvanq 65628-0204-05 Azurity 1 kit — AA FDA listed —
Firvanq 65628-0208-10 Azurity 1 kit — AA FDA listed —
vancomycin hydrochloride 59651-0670-03 Aurobindo 1 kit — AA FDA listed —
vancomycin hydrochloride 59651-0669-03 Aurobindo 1 kit — AA FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2018
First FDA approval
Jan 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 26, 2018 AA TE-rated RLD RS ⏳ ~8.5 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 10959947 — method of use (U-3105)
US 10959947 — method of use (U-3104)
US 10959948 — method of use (U-3105)
US 10959948 — method of use (U-3104)
US 10959949 — method of use (U-3104)
US 10959949 — method of use (U-3105)
US 10959947 — method of use (U-3104)
US 10959947 — method of use (U-3105)
US 10959948 — method of use (U-3104)
US 10959948 — method of use (U-3105)
US 10959949 — method of use (U-3105)
US 10959949 — method of use (U-3104)
US 11638692 — drug product
US 10493028 — drug product
US 10688046 — drug product
US 10688046 — drug product
US 10959946 — drug product
US 10959946 — drug product
US 10493028 — drug product
US 11638692 — drug product
2018 2020 2022 2024 2026 2028 2030 2032 2034
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 (20)
PatentTypeUse codeExpires
US 10959947 ↗ Method of use U-3105 Mar 13, 2035
US 10959947 ↗ Method of use U-3104 Mar 13, 2035
US 10959948 ↗ Method of use U-3105 Mar 13, 2035
US 10959948 ↗ Method of use U-3104 Mar 13, 2035
US 10959949 ↗ Method of use U-3104 Mar 13, 2035
US 10959949 ↗ Method of use U-3105 Mar 13, 2035
US 10959947 ↗ Method of use U-3104 Mar 13, 2035
US 10959947 ↗ Method of use U-3105 Mar 13, 2035
US 10959948 ↗ Method of use U-3104 Mar 13, 2035
US 10959948 ↗ Method of use U-3105 Mar 13, 2035
US 10959949 ↗ Method of use U-3105 Mar 13, 2035
US 10959949 ↗ Method of use U-3104 Mar 13, 2035
US 11638692 ↗ Drug product — Mar 13, 2035
US 10493028 ↗ Drug product — Mar 13, 2035
US 10688046 ↗ Drug product — Mar 13, 2035
US 10688046 ↗ Drug product — Mar 13, 2035
US 10959946 ↗ Drug product — Mar 13, 2035
US 10959946 ↗ Drug product — Mar 13, 2035
US 10493028 ↗ Drug product — Mar 13, 2035
US 11638692 ↗ Drug product — Mar 13, 2035
Common questions
Is there a generic version of FIRVANQ 25 MG/ML SOLUTION?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for FIRVANQ 25 MG/ML SOLUTION. See the alternatives section for substitutable, lower-cost products.
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 Firvanq — 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 Firvanq. 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
$57.5K
Claims incl. refills
301
Beneficiaries
224
Spend / beneficiary
$256.80
Spend / claim
$191.11
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65628-0205-10 You're viewing this 1 KIT in 1 CARTON (65628-205-10) * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE 2018-01-26 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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

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 65628-205-10, 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: 65628-0205-10, written without dashes as 65628020510. 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 65628-0205-10, the first segment (65628) is the labeler code FDA assigned to Azurity Pharmaceuticals, Inc; the middle segment (0205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Azurity Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Azurity Pharmaceuticals, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE FIRVANQ is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.

Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug‑resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ 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. FIRVANQ is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: ( 1 ) Clostridium difficile ‑associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin‑resistant strains) Important Limitations of Use: ( 1 ) ( 5.1 ) Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION C. difficile‑ associated diarrhea: Adult Patients (18 years of age and older): 125 mg orally 4 times daily for 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

( 2.3 ) Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

( 2.3 ) See Full Prescribing Information for preparation and important administration information. ( 2.1 )

2.1Important Administration Instructions Prior to oral administration, the supplied FIRVANQ powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4 ) ].

2.2Adults C. difficile ‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

2.3Pediatric Patients (less than 18 years of age) For both C. difficile ‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of FIRVANQ is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

2.4Preparation and Storage of Solutions of FIRVANQ Each FIRVANQ kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre‑measured Grape‑Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape‑Flavored Diluent provided in the kit. FIRVANQ is available in various strengths and volumes in the kit as shown in Table 1 .

Table 1: Vancomycin Concentration and Volume after Reconstitution Vancomycin Concentration after Reconstitution Final Volume of FIRVANQ after Reconstitution Vancomycin Strength per Bottle Diluent for FIRVANQ 25 mg/mL 150 mL 3.75 g 147 mL 300 mL 7.5 g 295 mL 50 mg/mL 150 mL 7.5 g 145 mL 300 mL 15.0 g 289 mL Steps for the Preparation of Solutions of FIRVANQ Hold the neck of the bottle containing the vancomycin hydrochloride USP powder for oral solution (see Table 1 ), and tap the bottom edges on a hard surface to loosen the powder.

Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”). Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner. Carefully and slowly peel back the inner foil seal liner from the Powder Bottle.

Shake the Grape‑Flavored Diluent (see Table 1 ) for a few seconds. Remove the cap from the diluent bottle. Carefully and slowly peel back the inner foil seal from the diluent bottle.

Transfer approximately one-half the contents of Grape-Flavored Diluent into the Powder Bottle. Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle vertically for approximately 45 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle.

Re-open the Powder Bottle and add the remaining Grape‑Flavored Diluent into the Powder Bottle. Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle for approximately 30 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle.

Dispense the Powder Bottle containing reconstituted solution of FIRVANQ oral solution to the patient [ see Patient Counseling Information ( 17 ) ]. Instruct the patient to shake the reconstituted solution of FIRVANQ well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters. Store the reconstituted solution of FIRVANQ at refrigerated conditions, 2°C to 8°…

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS Each FIRVANQ kit contains vancomycin hydrochloride USP as white to almost white or tan to brown powder for oral solution, equivalent to 3.75 g, 7.5 g or 15.0 g vancomycin, and Grape‑Flavored Diluent for reconstitution. Each FIRVANQ kit contains: vancomycin hydrochloride USP, powder for oral solution, equivalent to 3.75 g, 7.5 g or 15.0 g vancomycin, and Grape‑Flavored Diluent. ( 3 )

⛔ Contraindications 18 words ▾

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

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS FIRVANQ must be given orally for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. ( 5.1 ) Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin hydrochloride for C. difficile ‑associated diarrhea.

Monitoring of serum concentrations may be appropriate in some instances. ( 5.2 ) Nephrotoxicity has occurred following oral vancomycin hydrochloride therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients.

Monitor renal function. ( 5.3 ) Ototoxicity has occurred in patients receiving vancomycin hydrochloride. Assessment of auditory function may be appropriate in some instances.

( 5.4 ) Severe Dermatologic Reactions: Discontinue FIRVANQ at the first appearance of skin rashes, mucosal lesions, or blisters. ( 5.5 ) Prescribing FIRVANQ 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. ( 5.7 )

5.1Oral Use Only FIRVANQ must be given orally for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin is not effective for treatment of other types of infections. Parenteral administration of vancomycin is not effective for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis.

If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the Full Prescribing Information accompanying that preparation.

5.2Potential for Systemic Absorption Significant systemic absorption has been reported in some patients (e.g., patients with renal insufficiency and/or colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile ‑associated diarrhea. In these patients, serum vancomycin concentrations reached therapeutic levels for the treatment of systemic infections. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin.

These patients may be at risk for the development of adverse reactions associated with higher doses of FIRVANQ; therefore, monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibacterial drug.

5.3Nephrotoxicity Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral vancomycin hydrochloride therapy in randomized controlled clinical trials and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients over 65 years of age [ see Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.5 ) ]. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with FIRVANQ to detect potential vancomycin- induced nephrotoxicity.

5.4Ototoxicity Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given high intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity [ see Adverse Reactions ( 6.2 ) ].

5.5Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear lgA b…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1‑855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C. difficile ‑associated diarrhea. In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily.

The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%), and 52% were male.

Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride‑treated subjects are shown in Table 2 . The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia. Table 2: Common (≥ 5%) Adverse Reactions* for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of C. difficile Associated Diarrhea * Adverse reaction rates were derived from the incidence of treatment‑emergent adverse events.

System/Organ Class Adverse Reaction Vancomycin Hydrochloride (%) (N=260) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration site conditions Pyrexia 9 Edema peripheral 6 Fatigue 5 Infections and infestations Urinary tract infection 8 Metabolism and nutrition disorders Hypokalemia 13 Musculoskeletal and connective tissue disorders Back pain 6 Nervous system disorders Headache 7 Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride.

Nephrotoxicity following vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin hydrochloride occurred in 6% of subjects over 65 years of age and 3% of subjects 65 years of age and younger [ see Warnings and Precautions ( 5.3 ) ]. Nephrotoxicity can also occur during oral vancomycin administration.

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects over 65 years of age than in subjects 65 years of age and younger [ see Use in Specific Populations ( 8.5 ) ]. Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride. The most common adverse events leading to discontinuation of vancomycin hydrochloride were C. difficile colitis (< 1%), nausea (< 1%), and vomiting (< 1%).

6.2Postmarketing Experience The following adverse reactions have been identified during post‑approval use of vancomycin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ototoxicity : Cases of hearing loss associated with intravenously administered vancomycin have been reported.

Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug [ see Warnings and Precautions ( 5.4 ) ]. Vertigo, dizziness, and tinnitus have been reported. Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exa…

🔄 Drug Interactions 16 words ▾

7 DRUG INTERACTIONS No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatrics : In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin induced nephrotoxicity. ( 5.3 ) ( 6.1 ) ( 8.5 ) ( 14.1 )

8.1Pregnancy Risk Summary There are no available data on FIRVANQ use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related 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 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 A published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin‑resistant S. aureus 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 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 culture and a high‑risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin 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 the equivalent 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).

8.2Lactation Risk Summary There are insufficient data to inform the levels of vancomycin in human milk. However, systemic absorption of vancomycin following oral administration is expected to be minimal [ see Clinical Pharmacology ( 12.3 ) ]. There are no data on the effects of FIRVANQ on the breastfed infant or milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FIRVANQ and any potential adverse effects on the breastfed infant from FIRVANQ or from the underlying maternal condition.

8.4Pediatric Use FIRVANQ is indicated in pediatric patients less than 18 years of age for the treatment of C. difficile ‑associated diarrhea and enterocolitis caused by S. aureus (including methicillin‑resistant strains) [ see Indications and Usage ( 1 ) and Dosage and Administration ( 2.3 ) ].

8.5Geriatric Use In clinical trials, 54% of vancomycin hydrochloride‑treated subjects were > 65 years of age. Of…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on FIRVANQ use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related 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 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 A published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin‑resistant S. aureus 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 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 culture and a high‑risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin 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 the equivalent 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).

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use FIRVANQ is indicated in pediatric patients less than 18 years of age for the treatment of C. difficile ‑associated diarrhea and enterocolitis caused by S. aureus (including methicillin‑resistant strains) [ see Indications and Usage ( 1 ) and Dosage and Administration ( 2.3 ) ].

🧓 Geriatric Use 186 words ▾

8.5Geriatric Use In clinical trials, 54% of vancomycin hydrochloride‑treated subjects were > 65 years of age. Of these, 40% were between the ages of > 65 and 75, and 60% were > 75 years of age. Clinical studies with vancomycin hydrochloride in C. difficile ‑associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy.

In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin-induced nephrotoxicity [ see Warnings and Precautions( 5.3 ), Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.1 ) ]. Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger [ see Clinical Studies ( 14.1 ) ]. Clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

🆘 Overdosage 51 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 ~2 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics Vancomycin is poorly absorbed after oral administration. During multiple dosing of vancomycin hydrochloride capsules at 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mcg/g in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%.

In anephric subjects with no inflammatory bowel disease who received vancomycin oral solution 2 g for 16 days, blood concentrations of vancomycin were ≤ 0.66 mcg/mL in 2 of 5 subjects. No measurable blood concentrations were attained in the other 3 subjects. Following doses of 2 g daily, concentrations of drug were > 3100 mcg/g in the feces and < 1 mcg/mL in the serum of subjects with normal renal function who had C. difficile ‑associated diarrhea.

After multiple‑dose oral administration of vancomycin, measurable serum concentrations may occur in patients with active C. difficile ‑associated diarrhea, and, in the presence of renal impairment, the possibility of accumulation exists. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly [ see Use in Specific Populations ( 8.5 ) ].

12.4Microbiology Mechanism of Action The bactericidal action of vancomycin against the vegetative cells of C. difficile and S. aureus results primarily from inhibition of cell‑wall biosynthesis. In addition, vancomycin alters bacterial‑cell‑membrane permeability and RNA synthesis. Mechanism of Resistance C. difficile Isolates of C. difficile generally have vancomycin minimal inhibitory concentrations (MICs) of < 1 mcg/mL; however, vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been reported.

The mechanism which mediates C. difficile 's decreased susceptibility to vancomycin has not been fully elucidated. S. aureus S. aureus isolates with vancomycin MICs as high as 1024 mcg/mL have been reported. The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.

Vancomycin has been shown to be active against susceptible isolates of the following bacteria in clinical infections [ see Indications and Usage ( 1 ) ]. Anaerobic gram‑positive bacteria C. difficile isolates associated with C. difficile ‑associated diarrhea. Gram‑positive bacteria S. aureus (including methicillin‑resistant isolates) associated with enterocolitis.

🧬 Mechanism of Action 16 words ▾

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

📦 How Supplied / Storage and Handling 133 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 5 . Table 5: Vancomycin Strength, Diluent Volume and National Drug Code (NDC) Numbers Vancomycin Strength per Bottle Diluent Volume for FIRVANQ NDC Numbers 3.75 g 147 mL 65628‑204‑05 7.5 g 295 mL 65628‑205‑10 7.5 g 145 mL 65628‑206‑05 15.0 g 289 mL 65628‑208‑10 Storage and Handling Store the FIRVANQ kit at refrigerated conditions, 2°C to 8°C (36°F to 46°F).

Store reconstituted solutions of FIRVANQ at 2°C to 8°C [ see Dosage and Administration ( 2.4 ) ]. Do not freeze. Keep container tightly closed.

Protect from light.

📋 Description 187 words ▾

11 DESCRIPTION FIRVANQ for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 •HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula: Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3 .

Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution Vancomycin Strength per Bottle Equivalent Amount of Vancomycin Hydrochloride per Bottle Diluent Volume for FIRVANQ Vancomycin Concentration after Reconstitution 3.75 g 3.84 g 147 mL 25 mg/mL 7.5 g 7.7 g 295 mL 7.5 g 7.7 g 145 mL 50 mg/mL 15.0 g 15.4 g 289 mL The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose.

Vancomycin hydrochloride structural formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking FIRVANQ immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters, [ see Warnings and Precautions ( 5.5 ) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including FIRVANQ should only be used to treat bacterial infections.

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

Important Administration and Storage Instructions Instruct the patient or caregiver to [ see Dosage and Administration ( 2.4 ) ]: Shake the reconstituted solutions of FIRVANQ well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters. Store the reconstituted solutions of FIRVANQ at refrigerated conditions, 2° C to 8° C (36° F to 46° F) when not in use. Discard reconstituted solutions of FIRVANQ after 14 days, or if it appears hazy or contains particulates.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65628-0204-05 · Azurity 65628-0206-05 · Azurity →
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.