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mupirocin 20 mg/g Ointment, 1 g — NDC 17856-0112-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

mupirocin 20 mg/g Ointment, 1 g — NDC 17856-0112-1 (Billing 17856-0112-01)

by ATLANTIC BIOLOGICALS CORP. · 1 g in 1 SYRINGE

This is a package of 1 g of mupirocin 20 mg/g Ointment from ATLANTIC BIOLOGICALS CORP., marketed since Oct 2009 and currently FDA-listed. It is this product's only package size.

NDC 17856-0112-01
🏷️ FDA NDC (as labeled) 17856-0112-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 17856-0112-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17856 labeler · 0112 product · 1 package
Package marketed since
May 8, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 g per package
Barcode (UPC-A, from the NDC)
3 1785601121 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17856-0112-1
Product NDC 17856-0112
11-digit billing NDC 17856011201
NCPDP billing unit GM — per gram (weight)
RxCUI 106346
UNII D0GX863OA5
Application # ANDA065123
SPL Set ID da2f7d4e-82c6-4790-8eea-3a97e5b30734
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 2009-10-30
Route TOPICAL
Dosage form OINTMENT
Substance MUPIROCIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 075728
GCN 40844
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% OINT TOPICAL SYRG
FDB brand name Mupirocin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075728
  • GCN: 40844
  • HICL (First Databank): 003385
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 106346
Why two NDCs? The FDA registers this code as 17856-0112-1 — a 5-4-1 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 package segment → 17856-0112-01. 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.

Clinical

Label name MUPIROCIN 2% OINT TOPICAL SYRG Ingredient Mupirocin
📗 Our plain-language guide HelloPharmacist
  • It treats certain bacterial skin infections. The ointment is for impetigo. The cream is for small infected cuts or wounds. Both target Staphylococcus aureus and Streptococcus pyoge...
  • Put a small amount on the infected area with a cotton swab or gauze, 3 times a day. You can cover it with gauze if you like. Follow your prescriber’s directions for how many days.
  • Check back with your prescriber if you don’t see improvement within 3 to 5 days. Stop and call if you have severe irritation. Get emergency help for hives, swelling or trouble brea...
  • No. It is not for the nose, eyes or other moist body surfaces. If it gets in your eyes, rinse well with water.
📖 Read our full Mupirocin guide →

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Mupirocin (3 interactions) — ranked by severity →
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.

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 $0.35 / 1 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
17856-0112-01 You're viewing this Main listing 1 g in 1 SYRINGE 2024-05-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mupirocin 20 mg/g 00093-1010-42 Teva 1 tube $0.146 AB Availability likely —
Mupirocin 20 mg/g 51672-1312-00 Sun 1 tube $0.146 AB Availability likely —
Mupirocin 20 mg/g 68462-0180-22 Glenmark 22 g $0.146 AB Availability likely —
Mupirocin 20 mg/g 21922-0073-04 Encube 1 tube $0.298 AB Availability likely —
mupirocin 20 mg/g 45802-0112-14 Padagis 1 tube $0.298 AB Availability likely —
Mupirocin 20 mg/g 00121-1076-00 PAI 100 tubes — AB FDA listed —
mupirocin 20 mg/gthis 17856-0112-01 ATLANTIC 1 g — 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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.

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.

🧪 Avoiding an ingredient? See Mupirocin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerATLANTIC BIOLOGICALS CORP.
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA065123 (ANDA)
Labeler code17856
First marketedOct 2009
Product typeHuman Prescription Drug
Portfolio110 products on file

More NDCs from ATLANTIC BIOLOGICALS CORP. labeler code 17856

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.

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: and . S. aureus S. pyogenes

⏱️ Dosage and Administration 47 words ▾

DOSAGE AND ADMINISTRATION A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

⚠️ Warnings 195 words ▾

WARNINGS Avoid contact with the eyes. In case of accidental contact, rinse well with water. In the event of sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued. - associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin, 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 . Clostridium difficile C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of 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 two months after the administration of antibacterial agents. C. difficile C. difficile If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of , and surgical evaluation should be instituted as clinically indicated. C. difficile C. difficile

🤒 Adverse Reactions 70 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: 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 in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.

🔄 Drug Interactions 22 words ▾

- Drug Interactions The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.

🤰 Pregnancy 88 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B - Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

2

🧒 Pediatric Use 163 words ▾

Pediatric Use - The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years. Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment USP, 2% in impetigo in pediatric subjects studied as part of the pivotal clinical trials (see ). CLINICAL STUDIES

Pediatrics - There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment USP, 2%.

The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Application of C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. 14 Following intravenous or oral administration, mupirocin is rapidly metabolized.

The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. 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. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

Microbiology - Mupirocin is an antibacterial agent produced by fermentation using the organism . Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA (tRNA) synthetase. Due to this unique mode of action, mupirocin does not demonstrate cross-resistance with other classes of antimicrobial agents.

Pseudomonas fluorescens 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 and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.

Because of the occurrence of mupirocin resistance in methicillin-resistant (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method. Staphylococcus aureus Staphylococcus aureu 1 ,2,3 Mupirocin is bactericidal at concentrations achieved by topical administration. Mupirocin is highly protein-bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.

Mupirocin has been shown to be active against susceptible strains of , both and in clinical trials (see INDICATIONS AND USAGE). The following data are available, . Mupirocin is active against most isolates of .

S. aureus and Streptococcus pyogenes in vitro in vitro but their clinical significance is unknown Staphylococcus epidermidis

📦 How Supplied / Storage and Handling 9 words ▾

HOW SUPPLIED NDC:17856-0112-1 in a SYRINGE of 1 OINTMENTS

📋 Description 92 words ▾

DESCRIPTION Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( )-(2 ,3 ,4 ,5 )-5-[(2 ,3 ,4 ,5 )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid.

The molecular formula of mupirocin is C H O and the molecular weight is 500.62. E S R R S S S S S H 26 44 9 The chemical structure is: CHEMICAL STRUCTURE

💬 Information for Patients 93 words ▾

Information for Patients - Use this medication only as directed by the healthcare provider. It is for external use only. Avoid contact with the eyes.

If Mupirocin Ointment USP, 2% gets in or near the eyes, rinse thoroughly with water. The medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact the healthcare provider. - Drug Interactions The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying.

A paraffin-based formulation - *Bactroban Nasal® (mupirocin calcium ointment ) - is available for intranasal use. 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 USP, 2% 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.

Mupirocin Ointment USP, 2% should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance. Information for Patients - Use this medication only as directed by the healthcare provider. It is for external use only.

Avoid contact with the eyes. If Mupirocin Ointment USP, 2% gets in or near the eyes, rinse thoroughly with water. The medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.

If impetigo has not improved in 3 to 5 days, contact the healthcare provider. - Drug Interactions The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. Results of the following studies performed with mupirocin calcium or mupirocin sodium and did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, reversion test (Ames), mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice. in vitro in vivo Salmonella Escherichia coli Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

2 Pregnancy: Teratogenic Effects: Pregnancy Category B - Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

2 Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman. Pediatric Use - The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years.

Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment USP, 2% in impetigo in pediatric subjects studied as part of the pivotal clinical trials (see ). CLINICAL STUDIES

🍼 Nursing Mothers 38 words ▾

Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman.

🔬 Clinical Studies ~1 min read ▾

CLINICAL STUDIES The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51).

Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days.

There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable populations were 100% for both test groups.

There were no side effects reported in the group receiving mupirocin ointment USP, 2%. Pediatrics - There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49).

In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 125 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. Results of the following studies performed with mupirocin calcium or mupirocin sodium and did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, reversion test (Ames), mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice. in vitro in vivo Salmonella Escherichia coli Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

2

📄 Package Label / Principal Display Panel 4 words ▾

MUPIROCIN OINTMENT image description

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

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 ATLANTIC BIOLOGICALS CORP.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ATLANTIC BIOLOGICALS CORP. 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.
← 17856-0109-01 · ATLANTIC 17856-0114-01 · ATLANTIC →
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.