micafungin

Generic: micafungin sodium

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

Drug Facts

Product Profile

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

micafungin sodium 50 mg/5mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-028
Product ID 71288-028_9571440f-2c9b-4281-b907-0d53408d744e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215381
Listing Expiration 2026-12-31
Marketing Start 2022-09-28

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288028
Hyphenated Format 71288-028

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 ANDA215381 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)
source: ndc

Packages (2)

71288-028-11 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10) 71288-028-12 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)

Ingredients (1)

micafungin sodium (50 mg/5mL)

Linked Drug Pages (1)

Micafungin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9571440f-2c9b-4281-b907-0d53408d744e", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["579ff093-0359-4e0e-a6ea-2b6adac80bf0"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-11)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)", "package_ndc": "71288-028-11", "marketing_start_date": "20220928"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-028-12)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-028-10)", "package_ndc": "71288-028-12", "marketing_start_date": "20241101"}], "brand_name": "Micafungin", "product_id": "71288-028_9571440f-2c9b-4281-b907-0d53408d744e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "71288-028", "generic_name": "Micafungin sodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "50 mg/5mL"}], "application_number": "ANDA215381", "marketing_category": "ANDA", "marketing_start_date": "20220928", "listing_expiration_date": "20261231"}