Ciprofloxacin Hydrochloride
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
- Ciprofloxacin Hydrochloride
- Generic name
- CIPROFLOXACIN HYDROCHLORIDE
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 5cf0f572-48fc-6a3a-e053-2991aa0a8437
- SPL ID
- 2d3feef9-74ea-c651-e063-6394a90a2ca3
- Version
- 6
- Effective date
- 2025-02-03
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:19:19
| 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 | NDA | 019992 | derived:openfda.application_number |
| application number | NDA019992 | openfda.application_number | |
| brand name | Ciprofloxacin Hydrochloride | openfda.brand_name | |
| generic name | CIPROFLOXACIN HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | NuCare Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 68071-4139-5 | openfda.package_ndc |
| ndc | product | 68071-4139 | openfda.product_ndc |
| ndc11 | package | 68071413905 | derived:openfda.package_ndc |
| rxcui | 309307 | openfda.rxcui | |
| spl id | 2d3feef9-74ea-c651-e063-6394a90a2ca3 | id | |
| spl set id | 5cf0f572-48fc-6a3a-e053-2991aa0a8437 | set_id | |
| unii | 4BA73M5E37 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (SEE PRECAUTIONS). Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.