micafungin

Generic: micafungin

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin
Generic Name micafungin
Labeler par health usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 20 mg/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-230
Product ID 42023-230_9e300655-e1cc-4f04-9a9e-9b81688368dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212156
Listing Expiration 2026-12-31
Marketing Start 2021-08-01

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023230
Hyphenated Format 42023-230

Supplemental Identifiers

RxCUI
861379 861383
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 NDA212156 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

42023-230-10 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "9e300655-e1cc-4f04-9a9e-9b81688368dc", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["70b3f044-95ca-4503-b669-ed39972592b6"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "42023-230-10", "marketing_start_date": "20210801"}], "brand_name": "Micafungin", "product_id": "42023-230_9e300655-e1cc-4f04-9a9e-9b81688368dc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "42023-230", "generic_name": "Micafungin", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "20 mg/mL"}], "application_number": "NDA212156", "marketing_category": "NDA", "marketing_start_date": "20210801", "listing_expiration_date": "20261231"}