Tobramycin
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Tobramycin
- Generic name
- TOBRAMYCIN
- Manufacturer
- Sportpharm LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e2aa8499-2eab-4ea2-b122-6c7b1ad0c35c
- SPL ID
- 4d6e6b1d-8143-3586-e063-6394a90a4d97
- Version
- 1
- Effective date
- 2026-03-20
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:04
| Harmonized routes |
|---|
| OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 207444 | derived:openfda.application_number |
| application number | ANDA207444 | openfda.application_number | |
| brand name | Tobramycin | openfda.brand_name | |
| generic name | TOBRAMYCIN | openfda.generic_name | |
| manufacturer name | Sportpharm LLC | openfda.manufacturer_name | |
| ndc | package | 85766-189-05 | openfda.package_ndc |
| ndc | product | 85766-189 | openfda.product_ndc |
| ndc11 | package | 85766018905 | derived:openfda.package_ndc |
| rxcui | 313415 | openfda.rxcui | |
| spl id | 4d6e6b1d-8143-3586-e063-6394a90a4d97 | id | |
| spl set id | e2aa8499-2eab-4ea2-b122-6c7b1ad0c35c | set_id | |
| unii | VZ8RRZ51VK | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to tobramycin ophthalmic solution 0.3% occurs, discontinue use.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The most frequent adverse reactions to tobramycin ophthalmic solution 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution 0.3%. Postmarketing Experience: Additional adverse reactions identified from post-marketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.