micafungin

Generic: micafungin sodium

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

micafungin sodium 100 mg/5mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-191
Product ID 25021-191_edf05767-b6ad-4236-ac59-6c63ec6869f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213363
Listing Expiration 2026-12-31
Marketing Start 2021-06-15

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021191
Hyphenated Format 25021-191

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 ANDA213363 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-191-10) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL
  • 20 VIAL in 1 CARTON (25021-191-12) / 5 mL in 1 VIAL
source: ndc

Packages (3)

25021-191-10 1 VIAL in 1 CARTON (25021-191-10) / 5 mL in 1 VIAL 25021-191-11 10 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL 25021-191-12 20 VIAL in 1 CARTON (25021-191-12) / 5 mL in 1 VIAL

Ingredients (1)

micafungin sodium (100 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": "edf05767-b6ad-4236-ac59-6c63ec6869f0", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["33e579c1-b315-44cb-a690-e2dd2cdf44ee"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-191-10)  / 5 mL in 1 VIAL", "package_ndc": "25021-191-10", "marketing_start_date": "20210615"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-191-11)  / 5 mL in 1 VIAL", "package_ndc": "25021-191-11", "marketing_start_date": "20220915"}, {"sample": false, "description": "20 VIAL in 1 CARTON (25021-191-12)  / 5 mL in 1 VIAL", "package_ndc": "25021-191-12", "marketing_start_date": "20251101"}], "brand_name": "Micafungin", "product_id": "25021-191_edf05767-b6ad-4236-ac59-6c63ec6869f0", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "25021-191", "generic_name": "Micafungin Sodium", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "100 mg/5mL"}], "application_number": "ANDA213363", "marketing_category": "ANDA", "marketing_start_date": "20210615", "listing_expiration_date": "20261231"}