micafungin

Generic: micafungin

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin
Generic Name micafungin
Labeler biocon pharma inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 20 mg/mL

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-076
Product ID 70377-076_94972438-1ece-f99c-c2a5-e29821e7e9d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216438
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70377076
Hyphenated Format 70377-076

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 ANDA216438 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70377-076-91) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

70377-076-91 10 VIAL, SINGLE-DOSE in 1 CARTON (70377-076-91) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "94972438-1ece-f99c-c2a5-e29821e7e9d4", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861383"], "spl_set_id": ["5a74d7e9-1ca2-37dd-cbcf-d7fde1f5a606"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70377-076-91)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70377-076-91", "marketing_start_date": "20250601"}], "brand_name": "MICAFUNGIN", "product_id": "70377-076_94972438-1ece-f99c-c2a5-e29821e7e9d4", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "70377-076", "generic_name": "micafungin", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MICAFUNGIN", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "20 mg/mL"}], "application_number": "ANDA216438", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}