micafungin

Generic: micafungin sodium

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

Drug Facts

Product Profile

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

micafungin 50 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9361
Product ID 0143-9361_b73ed270-efe6-45d7-949c-b175415a9b5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213261
Listing Expiration 2026-12-31
Marketing Start 2021-07-09

Pharmacologic Class

Established (EPC)
echinocandin antifungal [epc]
Chemical Structure
lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439361
Hyphenated Format 0143-9361

Supplemental Identifiers

RxCUI
861379 861383
UNII
R10H71BSWG
NUI
N0000175507 M0519359

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 ANDA213261 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9361-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

0143-9361-01 1 VIAL in 1 CARTON (0143-9361-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

micafungin (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": "b73ed270-efe6-45d7-949c-b175415a9b5e", "openfda": {"nui": ["N0000175507", "M0519359"], "unii": ["R10H71BSWG"], "rxcui": ["861379", "861383"], "spl_set_id": ["8ba6f80c-05f0-4d75-930c-c8458db2e1c1"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Echinocandin Antifungal [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9361-01)  / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0143-9361-01", "marketing_start_date": "20210709"}], "brand_name": "Micafungin", "product_id": "0143-9361_b73ed270-efe6-45d7-949c-b175415a9b5e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "0143-9361", "generic_name": "Micafungin sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN", "strength": "50 mg/1"}], "application_number": "ANDA213261", "marketing_category": "ANDA", "marketing_start_date": "20210709", "listing_expiration_date": "20261231"}