gynazole 1 100 mg/5g
butoconazole nitrate · CREAM · Padagis Israel Pharmaceuticals Ltd
gynazole 1 is a cream containing butoconazole nitrate at 100 mg/5g, taken vaginal. Manufactured by Padagis Israel Pharmaceuticals Ltd.
Key Facts
- Brand Name
- gynazole 1
- Generic Name
- butoconazole nitrate
- NDC Code (Product)
45802-396- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Strength
- 100 mg/5g
- Dosage Form
- CREAM
- Route
- VAGINAL
- Marketing Status
- Application #
- ANDA200923
- Marketing Start
- 04/29/2015
Recall History
Padagis US LLC
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Frequently Asked Questions
What is gynazole 1 used for?
gynazole 1 contains butoconazole nitrate. It is a cream taken vaginal. Consult your doctor for specific uses.
Is gynazole 1 a controlled substance?
gynazole 1 is not classified as a controlled substance by the DEA.
What is the generic name for gynazole 1?
The generic name for gynazole 1 is butoconazole nitrate. There are no other listed brand versions of butoconazole nitrate.
What is the NDC code for gynazole 1 100 mg/5g?
The NDC (National Drug Code) for gynazole 1 100 mg/5g is 45802-396, listed by Padagis Israel Pharmaceuticals Ltd.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)