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NDC 71288-0028-11 Micafungin 50 mg/5mL Details
Micafungin 50 mg/5mL
Micafungin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is MICAFUNGIN SODIUM.
Product Information
| NDC | 71288-0028 |
|---|---|
| Product ID | 71288-028_0e9e0561-832f-42b8-9e7f-692df6e2c59c |
| Associated GPIs | |
| GCN Sequence Number | 058872 |
| GCN Sequence Number Description | micafungin sodium VIAL 50 MG INTRAVEN |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 24397 |
| HICL Sequence Number | 032804 |
| HICL Sequence Number Description | MICAFUNGIN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Micafungin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Micafungin sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | MICAFUNGIN SODIUM |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Pharmaceutical Class | Echinocandin Antifungal [EPC], Lipopeptides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215381 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0028-11 (71288002811)
| NDC Package Code | 71288-028-11 |
|---|---|
| Billing NDC | 71288002811 |
| Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10) |
| Marketing Start Date | 2022-09-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |