NDC 45802-396 – Gynazole 1
Butoconazole Nitrate 100 mg/5g · Cream · Vaginal
Product NDC45802-396
Product details
- Brand name
- Gynazole 1
- Generic name
- Butoconazole nitrate
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Dosage form
- Cream
- Route
- Vaginal
- Marketing category
- ANDA · ANDA200923
- Marketed since
- April 29, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Azole Antifungal
Active ingredients
- Butoconazole Nitrate 100 mg/5g
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 45802-396-01 | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR | Apr 29, 2015 |
| 45802-396-02 sample | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR | Apr 29, 2015 |
Recalls mentioning this NDC
- D-0081-2024 Nov 8, 2023 · Class II
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.