micafungin

Generic: micafungin

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin
Generic Name micafungin
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 20 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1725
Product ID 70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215241
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101725
Hyphenated Format 70710-1725

Supplemental Identifiers

RxCUI
861379 861383
UPC
0370710172411 0370710172510
UNII
IS1UP79R56

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name micafungin (source: ndc)
Generic Name micafungin (source: ndc)
Application Number ANDA215241 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70710-1725-1) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70710-1725-6) / 5 mL in 1 VIAL
source: ndc

Packages (2)

70710-1725-1 1 VIAL in 1 CARTON (70710-1725-1) / 5 mL in 1 VIAL 70710-1725-6 10 VIAL in 1 CARTON (70710-1725-6) / 5 mL in 1 VIAL

Ingredients (1)

micafungin sodium (20 mg/mL)

Linked Drug Pages (1)

Micafungin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ae363dc7-b3b5-41e8-8f04-82e30cf3c718", "openfda": {"upc": ["0370710172411", "0370710172510"], "unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["29f17423-5787-47d0-a83b-bbdc0198fbfa"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70710-1725-1)  / 5 mL in 1 VIAL", "package_ndc": "70710-1725-1", "marketing_start_date": "20240820"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70710-1725-6)  / 5 mL in 1 VIAL", "package_ndc": "70710-1725-6", "marketing_start_date": "20230410"}], "brand_name": "Micafungin", "product_id": "70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "70710-1725", "generic_name": "Micafungin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "20 mg/mL"}], "application_number": "ANDA215241", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}