micafungin

Generic: micafungin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin
Generic Name micafungin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 100 mg/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-729
Product ID 63323-729_e9aa7e59-831f-4994-802b-b62221fdfca3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207344
Listing Expiration 2026-12-31
Marketing Start 2020-05-08

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323729
Hyphenated Format 63323-729

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 sodium (source: ndc)
Application Number ANDA207344 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (63323-729-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-729-10 10 CARTON in 1 CARTON (63323-729-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

micafungin sodium (100 mg/1)

Linked Drug Pages (2)

Micafungin ndc-match (0.9) Micafungin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e9aa7e59-831f-4994-802b-b62221fdfca3", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["dc5241be-4b85-4f04-8553-9819603373b8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (63323-729-10)  / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-729-10", "marketing_start_date": "20200508"}], "brand_name": "Micafungin", "product_id": "63323-729_e9aa7e59-831f-4994-802b-b62221fdfca3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "63323-729", "generic_name": "Micafungin Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA207344", "marketing_category": "ANDA", "marketing_start_date": "20200508", "listing_expiration_date": "20261231"}