micafungin

Generic: micafungin

Labeler: northstar rx llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin
Generic Name micafungin
Labeler northstar rx llc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 20 mg/mL

Manufacturer
Northstar Rx LLC.

Identifiers & Regulatory

Product NDC 16714-301
Product ID 16714-301_c7c5d9d8-ad03-4705-a741-6629e51a3541
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215241
Marketing Start 2022-11-01
Marketing End 2026-04-30

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714301
Hyphenated Format 16714-301

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 ANDA215241 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (16714-301-10) / 5 mL in 1 VIAL (16714-301-01)
source: ndc

Packages (1)

16714-301-10 10 VIAL in 1 CARTON (16714-301-10) / 5 mL in 1 VIAL (16714-301-01)

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": "c7c5d9d8-ad03-4705-a741-6629e51a3541", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["9f4e9192-cb74-4018-90a2-69f9f21dd667"], "manufacturer_name": ["Northstar Rx LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (16714-301-10)  / 5 mL in 1 VIAL (16714-301-01)", "package_ndc": "16714-301-10", "marketing_end_date": "20260429", "marketing_start_date": "20221101"}], "brand_name": "Micafungin", "product_id": "16714-301_c7c5d9d8-ad03-4705-a741-6629e51a3541", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "16714-301", "generic_name": "Micafungin", "labeler_name": "Northstar Rx LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "20 mg/mL"}], "application_number": "ANDA215241", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20221101"}