Mupirocin 20 mg/g
Mupirocin · OINTMENT · Teva Pharmaceuticals USA, Inc.
Mupirocin is a ointment containing mupirocin at 20 mg/g, taken topical. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Mupirocin
- Generic Name
- Mupirocin
- NDC Code (Product)
0093-1010- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- 20 mg/g
- Dosage Form
- OINTMENT
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA065085
- Drug Class
- RNA Synthetase Inhibitor Antibacterial [EPC]
- Marketing Start
- 11/07/2003
Recall History
GlaxoSmithKline, LLC.
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
GlaxoSmithKline, LLC
Penicillin Cross Contamination
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
GlaxoSmithKline, LLC.
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
GlaxoSmithKline, LLC
Penicillin Cross Contamination
GlaxoSmithKline, LLC.
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
GlaxoSmithKline, LLC
Penicillin Cross Contamination
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mupirocin cream 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 & Administration
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 )
Contraindications
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 )
Adverse Reactions
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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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%),…
Frequently Asked Questions
What is Mupirocin used for?
Mupirocin contains Mupirocin. It is a ointment taken topical. Consult your doctor for specific uses.
Is Mupirocin a controlled substance?
Mupirocin is not classified as a controlled substance by the DEA.
What is the generic name for Mupirocin?
The generic name for Mupirocin is Mupirocin. There are 7 other brand versions of Mupirocin.
What is the NDC code for Mupirocin 20 mg/g?
The NDC (National Drug Code) for Mupirocin 20 mg/g is 0093-1010, listed by Teva Pharmaceuticals USA, Inc..