micafungin

Generic: micafungin

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

Drug Facts

Product Profile

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

micafungin sodium 50 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-022
Product ID 42658-022_46233ce4-c0d3-aaea-e063-6294a90a7b93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219712
Listing Expiration 2026-12-31
Marketing Start 2025-12-31

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658022
Hyphenated Format 42658-022

Supplemental Identifiers

RxCUI
861379 861383
UPC
0342658022011 0342658023018
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 ANDA219712 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 BOX (42658-022-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
  • 10 BOX in 1 CARTON (42658-022-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
source: ndc

Packages (2)

42658-022-01 1 VIAL in 1 BOX (42658-022-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 42658-022-02 10 BOX in 1 CARTON (42658-022-02) / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Ingredients (1)

micafungin sodium (50 mg/1)

Linked Drug Pages (1)

Micafungin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "46233ce4-c0d3-aaea-e063-6294a90a7b93", "openfda": {"upc": ["0342658022011", "0342658023018"], "unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["230fcff4-ad4b-ea25-e063-6394a90a1fab"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (42658-022-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "42658-022-01", "marketing_start_date": "20251231"}, {"sample": false, "description": "10 BOX in 1 CARTON (42658-022-02)  / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL", "package_ndc": "42658-022-02", "marketing_start_date": "20251231"}], "brand_name": "Micafungin", "product_id": "42658-022_46233ce4-c0d3-aaea-e063-6294a90a7b93", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "42658-022", "generic_name": "Micafungin", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA219712", "marketing_category": "ANDA", "marketing_start_date": "20251231", "listing_expiration_date": "20261231"}