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MUPIROCIN 20 mg/g Ointment — NDC 21922-0073-05 package photo

MUPIROCIN 20 mg/g Ointment

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON (21922-073-05) / 30 g in 1 TUBE
NDC 21922-0073-05
🏷️ FDA NDC (as labeled) 21922-073-05 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Pack sizes3 compare ↓
Also priced by: Part D plans $0.3533/unit — full pricing hub ↓
Rx only Generic 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 →

🆔 Identity & classification

FDA NDC (as labeled) 21922-073-05
Product NDC 21922-073
11-digit billing NDC 21922007305
RxCUI 106346
UNII D0GX863OA5
UPC 0321922073041, 0321922073058, 0321922073256
Application # ANDA217943
SPL Set ID 95c302b8-affa-431a-9b89-0506f5a098e6
Established class (EPC) RNA Synthetase Inhibitor Antibacterial
Mechanism of action RNA Synthetase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-16
Route TOPICAL
Dosage form OINTMENT
Substance MUPIROCIN
GPI-14 90100065104210
GCN Seq No 007732
GCN 47450
HICL code 003385
Ingredient (HICL) Mupirocin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name MUPIROCIN 2% OINTMENT
FDB brand name Mupirocin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 21922-073-05 — 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 → 21922-0073-05. 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 RNA Synthetase Inhibitor Antibacterial class.

Pharmacologic class RNA Synthetase Inhibitor Antibacterial
Drug family (ATC) Other antibiotics for topical use, Other nasal preparations
How it works RNA Synthetase Inhibitors
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

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA217943 (ANDA)
Labeler code21922
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio77 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 MUPIROCIN 2% OINTMENT Ingredient Mupirocin
📗 Our plain-language guide HelloPharmacist
  • Mupirocin is a topical antibiotic — meaning it's applied directly to the skin. The ointment form is used to treat impetigo, which is a contagious bacterial skin infection common in...
  • Apply a small amount — about the size of a pea — to the affected area three times a day using a cotton swab or gauze pad. You can cover the area with a gauze dressing if you'd like...
  • How do I apply it, and how long do I use it?
  • Most people do just fine with mupirocin. The most common side effects are headache, nausea, rash, and a little burning or itching where you applied it. Those are usually mild and g...
📖 Read our full Mupirocin guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Mupirocin — tap one for details:

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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.

2 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 DailyMedingredient 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 gPer 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 $0.3533 $10.60 / 30 g
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
Mupirocin 20 mg/g 00093-1010-42 Teva 1 tube $0.145 AB Availability likely
Mupirocin 20 mg/g 51672-1312-00 Sun 1 tube $0.145 AB Availability likely
Mupirocin 20 mg/g 68462-0180-22 Glenmark 22 g $0.145 AB Availability likely
mupirocin 20 mg/g 45802-0112-14 Padagis 1 tube $0.299 AB Availability likely
Mupirocin 20 mg/g 00121-1076-00 PAI 100 tubes AB FDA listed
mupirocin 20 mg/g 17856-0112-01 ATLANTIC 1 g AB FDA listed
Mupirocin 20 mg/gthis 21922-0073-05 Encube 1 tube AB FDA listed
mupirocin 20 mg/g 50090-1587-00 A-S 1 tube AB FDA listed
Mupirocin 20 mg/g 50268-0568-15 AvPAK 50 tubes AB FDA listed
mupirocin 20 mg/g 60760-0960-22 St. 1 tube AB FDA listed
Mupirocin 20 mg/g 61919-0158-22 DIRECT 20 g AB FDA listed
Mupirocin 20 mg/g 63187-0015-22 Proficient 22 g AB FDA listed
Mupirocin 20 mg/g 63187-0151-22 Proficient 1 tube AB FDA listed
mupirocin 20 mg/g 63187-0261-22 Proficient 1 tube AB FDA listed
Mupirocin 20 mg/g 63187-0525-22 Proficient 1 tube AB FDA listed
mupirocin 20 mg/g 63629-8687-01 Bryant 1 tube AB FDA listed
Mupirocin 20 mg/g 67296-2211-01 Redpharm 1 tube AB FDA listed
Mupirocin 20 mg/g 68071-4111-02 NuCare 22 g AB FDA listed
Mupirocin 20 mg/g 68071-4321-02 NuCare 22 g AB FDA listed
mupirocin 20 mg/g 68071-4789-02 NuCare 22 g AB FDA listed
Mupirocin 20 mg/g 68788-8534-02 Preferred 22 g AB FDA listed
mupirocin 20 mg/g 68788-8642-02 Preferred 1 tube AB FDA listed
Mupirocin 20 mg/g 70166-0355-10 Lohxa 100 tubes AB FDA listed
mupirocin 20 mg/g 70518-1808-00 REMEDYREPACK 1 tube AB FDA listed
mupirocin 20 mg/g 71335-2829-01 Bryant 1 tube AB FDA listed
mupirocin 20 mg/g 72162-2270-02 Bryant 1 tube AB FDA listed
mupirocin 20 mg/g 76420-0128-22 Asclemed 22 g AB FDA listed
Mupirocin 20 mg/g 80425-0246-01 Advanced 1 tube AB FDA listed
Mupirocin 20 mg/g 80425-0254-01 Advanced 1 tube AB FDA listed
Mupirocin 20 mg/g 81033-0032-50 Kesin 50 tubes AB FDA listed
Mupirocin 20 mg/g 85766-0207-15 Sportpharm 1 tube AB FDA listed
mupirocin 20 mg/g 85534-0038-00 HAWAII 1 tube AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube21922-0073-25 58,290 Rx · $639,735
1 tube21922-0073-04 272 Rx · $5,258
Drug total (last 4 qtrs): 58,562 Rx · 1,336,794 units · $644,994 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Mupirocin — the program that covers self-administered drugs. 5 manufacturers.
⚠️ 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 Mupirocin. 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
$9.08M
Claims incl. refills
1.1M
Beneficiaries
906.8K
Spend / beneficiary
$10.01
Spend / claim
$8.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Nausea955
Pain937
Fatigue821
Macular Degeneration820
Headache765
Diarrhoea705
Rash616

Reporter sex

13,756 reports

Serious outcomes

Hospitalization3,639
Death942
Life-threatening294
Disabling198
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,408 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 Per unit Per pack Marketing startStatus
21922-0073-04 1 TUBE in 1 CARTON (21922-073-04) / 15 g in 1 TUBE $0.2988 / g $4.48 2025-05-16 Active
21922-0073-05 You're viewing this 1 TUBE in 1 CARTON (21922-073-05) / 30 g in 1 TUBE 2025-05-16 Active
21922-0073-25 1 TUBE in 1 CARTON (21922-073-25) / 22 g in 1 TUBE $0.1454 / g $3.20 2025-05-16 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 21922-0073-05?
NDC 21922-0073-05 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of MUPIROCIN 20 mg/g Ointment?
Bill NDC 21922-0073-05 — the 11-digit billing format is 21922007305. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 — 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

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 21922-073-05, 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: 21922-0073-05, written without dashes as 21922007305. 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 21922-0073-05, the first segment (21922) is the labeler code FDA assigned to Encube Ethicals, Inc.; the middle segment (0073) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Encube Ethicals, 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 2 other package presentations of this same product, including 1 tube (21922-0073-04), 1 tube (21922-0073-25). 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?
Encube Ethicals, 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 59 words

1 INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. ( 1 )

⏱️ Dosage and Administration 170 words

2 DOSAGE AND ADMINISTRATION • For Topical Use Only. • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. • Cover the treated area with gauze dressing if desired. • Re-evaluate patients not showing a clinical response within 3 to 5 days. • Mupirocin ointment is not for intranasal, ophthalmic, or other mucosal use [ see Warnings and Precautions ( 5.2 , 5.6 ) ]. • Do not apply mupirocin ointment concurrently with any other lotions, creams, or ointments [ see Clinical Pharmacology ( 12.3 ) ]. • For Topical Use Only.

( 2 ) • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. ( 2 ) • Re-evaluate patients not showing a clinical response within 3 to 5 days. ( 2 ) • Not for intranasal, ophthalmic, or other mucosal use.

( 2 )

💊 Dosage Forms and Strengths 53 words

3 DOSAGE FORMS AND STRENGTHS Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base supplied in 15-gram, 22-gram and 30-gram tubes. • Ointment: Each gram contains 20 mg mupirocin, USP in a water-miscible ointment base supplied in 15-gram, 22-gram and 30-gram tubes. ( 3 )

Contraindications 37 words

4 CONTRAINDICATIONS Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. • Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. ( 4 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS • Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including Mupirocin ointment. ( 5.1 ) • Eye Irritation: Avoid contact with eyes. ( 5.2 ) • Local Irritation: Discontinue in the event of sensitization or severe local irritation.

( 5.3 ) • Clostridium difficile -Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) • Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) • Risk Associated with Mucosal Use: Mupirocin ointment is not formulated for use on mucosal surfaces.

A separate formulation, mupirocin nasal ointment, is available for intranasal use. ( 5.6 ) • Risk of Polyethylene Glycol Absorption: Mupirocin ointment should not be used where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. ( 5.7 ) • Risk Associated with Use at Intravenous Sites: Mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.

( 5.8 )

5.1Severe Allergic Reactions Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of mupirocin, including mupirocin ointment [ see Adverse Reactions ( 6.2 ) ].

5.2Eye Irritation Avoid contact with the eyes. In case of accidental contact, rinse well with water.

5.3Local Irritation In the event of a sensitization or severe local irritation from mupirocin ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

5.4Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.5Potential for Microbial Overgrowth As with other antibacterial products, prolonged use of mupirocin ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [ see Dosage and Administration ( 2 ) ].

5.6Risk Associated with Mucosal Use Mupirocin ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, mupirocin calcium nasal ointment, is available for intranasal use.

5.7Risk of Polyethylene Glycol Absorption Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, mupirocin ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

5.8Risk Associated with Use at Intravenous Sites Mupirocin ointment should not be used with intravenous can…

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Severe Allergic Reactions [ see Warnings and Precautions ( 5.1 ) ] • Eye Irritation [ see Warnings and Precautions ( 5.2 ) ] • Local Irritation [ see Warnings and Precautions ( 5.3 ) ] • Clostridium difficile-Associated Diarrhea [ see Warnings and Precautions ( 5.4 ) ] • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following local adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects.

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin ointment. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin ointment.

Immune System Disorders Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [ see Warnings and Precautions ( 5.1 ) ].

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [ see Clinical Pharmacology (12.3) ]. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis.

This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes.

There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area. Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area.

The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

8.2Lactation Risk Summary It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin ointment [ see Clinical Pharmacology (12.3) ]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin ointment and any potential adverse effects on the breastfed child from mupirocin ointment or from the underlying maternal condition.

Clinical Considerations To minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin ointment should be thoroughly washed prior to breastfeeding.

8.4Pediatric Use The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials [ see Clinical Studies ( 14 ) ].

🤰 Pregnancy ~2 min read

8.1 Pregnancy

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [ see Clinical Pharmacology (12.3) ]. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis.

This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes.

There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area. Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area.

The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

🧒 Pediatric Use 64 words

8.4Pediatric Use The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials [ see Clinical Studies ( 14 ) ].

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mupirocin is an RNA synthetase inhibitor antibacterial [ see Microbiology ( 12.4 ) ].

12.2 Pharmacodynamics

12.3Pharmacokinetics Absorption Application of 14 C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (less than 1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. The effect of the concurrent application of mupirocin ointment with other topical products has not been studied [ see Dosage and Administration ( 2 ) ].

Elimination In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. Metabolism: Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.

Excretion: Monic acid is predominantly eliminated by renal excretion.

12.4Microbiology Mupirocin is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens. Mechanism of Action Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer RNA (tRNA) synthetase. Mupirocin is bactericidal at concentrations achieved by topical administration.

Mupirocin is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (MICs) of mupirocin has not been determined. Resistance When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC ≥512 mcg/mL) has been reported in increasing numbers of isolates of S. aureus and with higher frequency in coagulase-negative staphylococci.

Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin- susceptible staphylococci. Cross Resistance Due to its mode of action, mupirocin does not demonstrate cross resistance with other classes of antimicrobial agents. Antimicrobial Activity Mupirocin has been shown to be active against susceptible isolates of S. aureus and S. pyogenes , both in vitro and in clinical trials [ see Indications and Usage (1) ].

The following in vitro data are available, but their clinical significance is unknown. Mupirocin is active against most isolates of Staphylococcus epidermidis. Susceptibility Test Methods High-level mupirocin resistance (≥512 mcg/mL) may be determined using standard disk diffusion or broth microdilution tests.1,2 Because of the occurrence of mupirocin resistance in methicillin-resistant S. aureus (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method.

3,4,5

🧬 Mechanism of Action 18 words

12.1Mechanism of Action Mupirocin is an RNA synthetase inhibitor antibacterial [ see Microbiology ( 12.4 ) ].

📦 How Supplied / Storage and Handling 55 words

16 HOW SUPPLIED/STORAGE AND HANDLING Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: NDC 21922-073-04 (15-gram tube) NDC 21922-073-25 (22-gram tube) NDC 21922-073-05 (30-gram tube) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

📋 Description 95 words

11 DESCRIPTION Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is (E)- (2S,3R,4R,5S) -5-[ (2S,3S,4S,5S) -2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-β-methyl-2 H- pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26 H 44 O 9 , and the molecular weight is 500.6.

The structural formula of mupirocin, USP is: Figure 1. Structure of Mupirocin, USP Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Structure_mupirocin

💬 Information for Patients ~1 min read

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin ointment as follows: • Use mupirocin ointment only as directed by the healthcare provider. It is for external use only.

Avoid contact of mupirocin ointment with the eyes. If mupirocin ointment gets in the eyes, rinse thoroughly with water. • Do not use mupirocin ointment in the nose. • Wash your hands before and after applying mupirocin ointment. • Use a gauze pad or cotton swab to apply a small amount of mupirocin ointment to the affected area. The treated area may be covered by gauze dressing if desired. • Report to the healthcare provider any signs of local adverse reactions.

Mupirocin ointment should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. • Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur [ see Warnings and Precautions ( 5.1 ) ]. • If impetigo has not improved in 3 to 5 days, contact the healthcare provider. Trademarks are the property of their respective owners. Manufactured by: Encube Ethicals Pvt.

Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa – 403 404, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA Revised: 05/2025

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