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NDC 50090-4356-00 Miconazole Nitrate 20 mg/g Details
Miconazole Nitrate 20 mg/g
Miconazole Nitrate is a VAGINAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is MICONAZOLE NITRATE.
MedlinePlus Drug Summary
Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 50090-4356-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 50090-4356 |
|---|---|
| Product ID | 50090-4356_54de6aa4-851d-4611-be14-cc689050352f |
| Associated GPIs | 55104050103710 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Miconazole Nitrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miconazole Nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | MICONAZOLE NITRATE |
| Labeler Name | A-S Medication Solutions |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074444 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50090-4356-00 (50090435600)
| NDC Package Code | 50090-4356-0 |
|---|---|
| Billing NDC | 50090435600 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-4356-0) / 45 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 2019-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |