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Mupirocin 2 g/100g Cream — NDC 21922-0029-05 package photo

Mupirocin 2 g/100g Cream

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON (21922-029-05) / 30 g in 1 TUBE
NDC 21922-0029-05
🏷️ FDA NDC (as labeled) 21922-029-05 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.8388 NADAC Per package$25.16 / 30 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.03/unit · Part D plans $3.03/unit — full pricing hub ↓
Also comes in: 15 g 21922-0029-04
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) 21922-029-05
Product NDC 21922-029
11-digit billing NDC 21922002905
NCPDP billing unit GM — per gram (weight)
RxCUI 311877
UNII RG38I2P540
UPC 0321922029048, 0321922029055
Application # ANDA213076
SPL Set ID cb085bdf-e371-6e8a-e053-2995a90ae358
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 2021-09-02
Route TOPICAL
Dosage form CREAM
Substance MUPIROCIN CALCIUM
GPI-14 90100065203710
GPI class Mupirocin Calcium
GCN Seq No 037048
GCN 47459
HICL code 007527
Ingredient (HICL) Mupirocin Calcium
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% CREAM
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 21922-029-05 — 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 → 21922-0029-05. 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 applicationANDA213076 (ANDA)
Labeler code21922
First marketedSep 2021
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% CREAM Ingredient Mupirocin Calcium
📖 What it is MedlinePlus · NLM

Mupirocin, an antibiotic, is used to treat impetigo as well as other skin infections caused by bacteria. It is not effective against fungal or viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

7 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 $0.839 $25.16 / 30 g
Medicaid paysCMS SDUD · 12 mo $1.03 $30.97 / 30 g
Medicare drug plans payPart D · Q2 2026 $3.03 $90.96 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $7.034 $0.764
▼ Down 88% over the last 24 months.
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 2 g/100gthis 21922-0029-05 Encube 1 tube $0.839 AB Availability likely
Mupirocin 2 g/100g 69238-2029-03 Amneal 1 tube $0.839 AB Availability likely
Mupirocin 20 mg/g 16714-0055-01 NORTHSTAR 1 tube $0.907 AB Availability likely +8%
Mupirocin 20 mg/g 51672-1370-01 Sun 1 tube $0.907 AB Availability likely +8%
Mupirocin 20 mg/g 62332-0624-15 Alembic 1 tube $0.907 AB Availability likely +8%
Mupirocin 2 g/100g 68462-0564-17 Glenmark 15 g $0.907 AB Availability likely +8%
Mupirocin 20 mg/g 46708-0624-15 Alembic 1 tube AB FDA listed
Pirnuo 2 g/100g 68462-0560-47 Glenmark 1 bottle AB FDA listed
Mupirocin 20 mg/g 70518-3774-00 REMEDYREPACK 1 tube AB FDA listed
Mupirocin 2 g/100g 85766-0204-15 Sportpharm 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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 21922-0029-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
997
Units reimbursed last 4 qtrs
31K
Gross reimbursed last 4 qtrs
$32K
Avg / prescription
$32.06
Avg / unit
$1.0324
Latest quarter Q4 2025
405Rx
Medicaid pays / g
$1.0324
gross reimbursed
vs
NADAC / g
$0.8388
acquisition cost
=
Spread
+$0.1936
+23% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
44% FFS 56% MCO
Fee-for-service · 438 Rx Managed care · 559 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 4,702 units · 24.0 per 100k residents NY Vermont: no data reported VT New Hampshire: 360 units · 25.7 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 390 units · 5.7 per 100k residents IN Ohio: 9,390 units · 79.7 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,312 units · 11.1 per 100k residents CA Utah: no data reported UT Colorado: 1,170 units · 19.9 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 390 units · 8.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 1,230 units · 19.9 per 100k residents MD Connecticut: 1,020 units · 28.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,640 units · 35.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 2,265 units · 44.3 per 100k residents AL Georgia: 2,730 units · 24.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 360 units · 1.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.279.7
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 79.7 /100k
2 Alabama 44.3 /100k
3 Arizona 35.5 /100k
4 Connecticut 28.2 /100k
5 New Hampshire 25.7 /100k
6 Georgia 24.8 /100k
7 New York 24.0 /100k
8 Colorado 19.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube21922-0029-04 1,397 Rx · $36,411
1 tube this page21922-0029-05 997 Rx · $31,961
Drug total (last 4 qtrs): 2,394 Rx · 56,051 units · $68,373 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
21922-0029-04 1 TUBE in 1 CARTON (21922-029-04) / 15 g in 1 TUBE $0.9075 / g $13.61 2021-09-02 Active
21922-0029-05 You're viewing this 1 TUBE in 1 CARTON (21922-029-05) / 30 g in 1 TUBE $0.8388 / g $25.16 2021-09-02 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.8388 NADAC).

This pack accounts for about 42% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 21922-0029-05?
NDC 21922-0029-05 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 2 g/100g Cream?
Bill NDC 21922-0029-05 — the 11-digit billing format is 21922002905. 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.

📄 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 88 words

1 INDICATIONS AND USAGE Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes). Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes.

( 1 )

⏱️ Dosage and Administration 153 words

2 DOSAGE AND ADMINISTRATION For Topical Use Only. Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 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 cream is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions ( 5.2 , 5.6 )] . Do not apply mupirocin cream concurrently with any other lotions, creams, or ointments [see Clinical Pharmacology ( 12.3 )].

For Topical Use Only. ( 2 ) Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 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 63 words

3 DOSAGE FORMS AND STRENGTHS Mupirocin Cream USP, 2% m is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion, supplied in 15-gram and 30-gram tubes. Cream: 20 mg (2% w/w) of mupirocin per gram (equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium, USP) in 15-gram and 30-gram tubes. ( 3 )

Contraindications 36 words

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

⚠️ Warnings and Cautions ~2 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 cream. ( 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 cream is not formulated for use on mucosal surfaces.

A separate formulation, mupirocin nasal ointment, is available for intranasal use. ( 5.6 )

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 cream [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 cream, 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 cream may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration ( 2 )] .

5.6Risk Associated with Mucosal Use Mupirocin cream is not formulated for use on mucosal surfaces. A separate formulation, mupirocin nasal ointment, is available for intranasal use.

🤒 Adverse Reactions ~2 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 headache, rash, and nausea. ( 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. In 2 randomized, double-blind, double-dummy trials, 339 subjects were treated with topical mupirocin cream plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects.

The following adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin cream in clinical trials: headache (1.7%), rash (1.1%), and nausea (1.1%). Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis. In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with mupirocin cream.

The incidence of adverse reactions was as follows: nausea (4.9%), headache and burning at application site (3.6% each), pruritus (2.4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin cream. 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 cream.

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

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin cream [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 miscarriage 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 cream [see Clinical Pharmacology ( 12.3 )] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin cream and any potential adverse effects on the breastfed child from mupirocin cream 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 cream should be thoroughly washed prior to breastfeeding.

8.4Pediatric Use The safety and effectiveness of mupirocin cream have been established in the age-groups of 3 months to 16 years. Use of mupirocin cream in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies ( 14 )] .

8.5Geriatric Use In 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. No overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin cream [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 miscarriage 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 66 words

8.4Pediatric Use The safety and effectiveness of mupirocin cream have been established in the age-groups of 3 months to 16 years. Use of mupirocin cream in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies ( 14 )] .

🧓 Geriatric Use 45 words

8.5Geriatric Use In 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. No overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics Absorption Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of mupirocin cream 3 times daily for 5 days to various skin lesions greater than 10 cm in length or 100 cm 2 in area in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine.

Data from this trial indicated more frequent occurrence of percutaneous absorption in children (90% of subjects) compared with adults (44% of subjects); however, the observed urinary concentrations in children (0.07 to 1.3 mcg per mL [1 pediatric subject had no detectable level]) are within the observed range (0.08 to 10.03 mcg per mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children. The effect of the concurrent application of mupirocin cream 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 16 words

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

📦 How Supplied / Storage and Handling 64 words

16 HOW SUPPLIED/STORAGE AND HANDLING Mupirocin Cream USP, 2% is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion. Mupirocin Cream USP, 2% is supplied in 15-gram and 30-gram tubes. NDC 21922-029-04 (15-gram tube) NDC 21922-029-05 (30-gram tube) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

📋 Description 139 words

11 DESCRIPTION Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (α E, 2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium, USP is (C 26 H 43 O 9 ) 2 Ca•2H 2 O, and the molecular weight is 1075.3 g/mol.

The molecular weight of mupirocin free acid is 500.6 g/mol. The structural formula of mupirocin calcium, USP is: Each gram of mupirocin cream contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, polyoxyl 20 cetostearyl ether, mono and di-glycerides, mineral oil, phenoxyethanol, purified water and xanthan gum.

Structure

💬 Information for Patients ~1 min read

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

Avoid contact of mupirocin cream with the eyes. If mupirocin cream gets in the eyes, rinse thoroughly with water. Do not use mupirocin cream in the nose.

Wash your hands before and after applying mupirocin cream. Use a gauze pad or cotton swab to apply a small amount of mupirocin cream 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 cream 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 no improvement is seen in 3 to 5 days, contact the healthcare provider. Manufactured by: Encube Ethicals Private Limited Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.

Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev. 11/2021 PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT ---------------------------------------------------------------------------------------------------------------------------------------------------------------

💬 Patient Medication Information ~3 min read

Patient Information PATIENT INFORMATION MUPIROCIN (mue pir'oh sin) CREAM, for topical us e What is mupirocin cream? Mupirocin cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria called Staphylococcus aureus and Streptococcus pyogenes . It is not known if mupirocin cream is safe and effective in children under 3 months of age.

Who should not use mupirocin cream? Do not use mupirocin cream if: you are allergic to mupirocin or any of the ingredients in mupirocin cream. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin cream.

What should I tell my healthcare provider before using mupirocin cream? Before using mupirocin cream, tell your healthcare provider about all of your medical conditions including if you: are pregnant or plan to become pregnant. It is not known if mupirocin cream will harm your unborn baby.•are breastfeeding or plan to breastfeed.

It is not known if mupirocin passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin cream while breastfeeding. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not mix mupirocin cream with other lotions, creams, or ointments. How should I use mupirocin cream? Mupirocin cream is for use on the skin (topical).

Do not get mupirocin cream in your eyes, nose, mouth, or vagina (mucosal surfaces). Use mupirocin cream exactly as your healthcare provider tells you to use it. Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times each day.

Apply mupirocin cream for 10 days. It is important that you take the full course of mupirocin cream. Do not stop early because your symptoms may disappear before the infection is fully cleared.

Wash your hands before and after applying mupirocin cream. After applying mupirocin cream, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered. Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with mupirocin cream.

If you are breastfeeding and use mupirocin cream on your breast or nipple, wash the area well before breastfeeding your child. What are the possible side effects of mupirocin cream? Mupirocin cream may cause serious side effects, including: severe allergic reactions.

Stop using mupirocin cream and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction: hives trouble breathing or wheezing swelling of your face, lips, mouth, or tongue dizziness, fast heartbeat, or pounding in your chest a rash over your whole body eye irritation. Do not get mupirocin cream in your eyes. If mupirocin cream gets in your eyes, rinse your eyes well with water . irritation in the area mupirocin cream is used .

A rash may occur after using mupirocin cream and can be severe. Stop using mupirocin cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin cream. a type of diarrhea called clostridium difficile -associated diarrhea (CDAD). CDAD may happen in people who use or have used medicine to treat bacterial infections.

The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using mupirocin cream. The most common side effects of mupirocin cream include: headache rash nausea These are not all the possible side effects of mupirocin cream.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store mupirocin cream?

Store mupirocin cream at room temperature…

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.