micafungin

Generic: micafungin

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

Drug Facts

Product Profile

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

micafungin 10 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-771
Product ID 68462-771_31e74606-bccd-4276-bb20-a1933ce4ca25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219273
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462771
Hyphenated Format 68462-771

Supplemental Identifiers

RxCUI
861379 861383
UPC
0368462771013 0368462772010
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 (source: ndc)
Application Number ANDA219273 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68462-771-01) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (68462-771-10) / 5 mL in 1 VIAL
source: ndc

Packages (2)

68462-771-01 1 VIAL in 1 CARTON (68462-771-01) / 5 mL in 1 VIAL 68462-771-10 10 VIAL in 1 CARTON (68462-771-10) / 5 mL in 1 VIAL

Ingredients (1)

micafungin (10 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": "31e74606-bccd-4276-bb20-a1933ce4ca25", "openfda": {"nui": ["N0000175507", "M0519359"], "upc": ["0368462771013", "0368462772010"], "unii": ["R10H71BSWG"], "rxcui": ["861379", "861383"], "spl_set_id": ["31e74606-bccd-4276-bb20-a1933ce4ca25"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Echinocandin Antifungal [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68462-771-01)  / 5 mL in 1 VIAL", "package_ndc": "68462-771-01", "marketing_start_date": "20250630"}, {"sample": false, "description": "10 VIAL in 1 CARTON (68462-771-10)  / 5 mL in 1 VIAL", "package_ndc": "68462-771-10", "marketing_start_date": "20250630"}], "brand_name": "MICAFUNGIN", "product_id": "68462-771_31e74606-bccd-4276-bb20-a1933ce4ca25", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "68462-771", "generic_name": "Micafungin", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MICAFUNGIN", "active_ingredients": [{"name": "MICAFUNGIN", "strength": "10 mg/mL"}], "application_number": "ANDA219273", "marketing_category": "ANDA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}