mycamine

Generic: micafungin sodium

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

micafungin sodium 10 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-3250
Product ID 0469-3250_cf33a1ae-ae66-4e64-8a9b-42b81188b179
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021506
Listing Expiration 2026-12-31
Marketing Start 2005-03-16

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04693250
Hyphenated Format 0469-3250

Supplemental Identifiers

RxCUI
861379 861381 861383 861385
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 mycamine (source: ndc)
Generic Name micafungin sodium (source: ndc)
Application Number NDA021506 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0469-3250-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

micafungin sodium (10 mg/mL)

Linked Drug Pages (1)

Mycamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "cf33a1ae-ae66-4e64-8a9b-42b81188b179", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["861379", "861381", "861383", "861385"], "spl_set_id": ["a064c4a7-25ec-4a2c-afc2-703491a4a38b"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-10)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0469-3250-10", "marketing_start_date": "20050316"}], "brand_name": "Mycamine", "product_id": "0469-3250_cf33a1ae-ae66-4e64-8a9b-42b81188b179", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "0469-3250", "generic_name": "Micafungin sodium", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycamine", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "10 mg/mL"}], "application_number": "NDA021506", "marketing_category": "NDA", "marketing_start_date": "20050316", "listing_expiration_date": "20261231"}