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NDC 45802-0396-02 gynazole 1 100 mg/5g Details
gynazole 1 100 mg/5g
gynazole 1 is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is BUTOCONAZOLE NITRATE.
MedlinePlus Drug Summary
Butoconazole is used to treat yeast infections of the vagina. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 45802-0396-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Butoconazole Vaginal Cream
Product Information
| NDC | 45802-0396 |
|---|---|
| Product ID | 45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8 |
| Associated GPIs | 55104015123720 |
| GCN Sequence Number | 022144 |
| GCN Sequence Number Description | butoconazole nitrate CRM/PF APP 2 % VAGINAL |
| HIC3 | Q4F |
| HIC3 Description | VAGINAL ANTIFUNGALS |
| GCN | 28821 |
| HICL Sequence Number | 003032 |
| HICL Sequence Number Description | BUTOCONAZOLE NITRATE |
| Brand/Generic | Brand |
| Proprietary Name | gynazole 1 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | butoconazole nitrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5g |
| Substance Name | BUTOCONAZOLE NITRATE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200923 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0396-02 (45802039602)
| NDC Package Code | 45802-396-02 |
|---|---|
| Billing NDC | 45802039602 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 2015-04-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |