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mupirocin 20 mg/g Ointment, 1 g — NDC 17856-0112-01 package photo

mupirocin 20 mg/g Ointment, 1 g

by ATLANTIC BIOLOGICALS CORP. · 1 g in 1 SYRINGE (17856-0112-1)
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
🗂️ 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) 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
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
TE code (Orange Book) AB · RLD · RS
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.

🏭 Manufacturer & labeler

LabelerATLANTIC BIOLOGICALS CORP.
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA065123 (ANDA)
Labeler code17856
First marketedOct 2009
Product typeHuman Prescription Drug
Portfolio109 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% OINT TOPICAL SYRG Ingredient Mupirocin
📖 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 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 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 $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.

🔁 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 21922-0073-04 Encube 1 tube $0.299 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/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.

📊 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 Marketing startStatus
17856-0112-01 You're viewing this 1 g in 1 SYRINGE (17856-0112-1) 2024-05-08 Active

🧭 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 17856-0112-1, 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: 17856-0112-01, written without dashes as 17856011201. 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 17856-0112-01, the first segment (17856) is the labeler code FDA assigned to ATLANTIC BIOLOGICALS CORP.; the middle segment (0112) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 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.

📄 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 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.

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.