micafungin in sodium chloride

Generic: micafungin in sodium chloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name micafungin in sodium chloride
Generic Name micafungin in sodium chloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

micafungin sodium 100 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9053
Product ID 0338-9053_c4a06712-4236-4c33-b5ae-77db633e8303
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216142
Listing Expiration 2026-12-31
Marketing Start 2023-09-29

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389053
Hyphenated Format 0338-9053

Supplemental Identifiers

RxCUI
2667650 2667652 2667653
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 in sodium chloride (source: ndc)
Generic Name micafungin in sodium chloride (source: ndc)
Application Number NDA216142 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/100mL
source: ndc
Packaging
  • 12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

0338-9053-12 12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAG

Ingredients (1)

micafungin sodium (100 mg/100mL)

Linked Drug Pages (1)

Micafungin in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c4a06712-4236-4c33-b5ae-77db633e8303", "openfda": {"unii": ["IS1UP79R56"], "rxcui": ["2667650", "2667652", "2667653"], "spl_set_id": ["a95f901e-0ac4-4ec0-9720-9c6a066cd06c"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 CARTON in 1 CARTON (0338-9053-12)  / 1 BAG in 1 CARTON (0338-9053-01)  / 100 mL in 1 BAG", "package_ndc": "0338-9053-12", "marketing_start_date": "20230929"}], "brand_name": "Micafungin in Sodium Chloride", "product_id": "0338-9053_c4a06712-4236-4c33-b5ae-77db633e8303", "dosage_form": "INJECTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "0338-9053", "generic_name": "Micafungin in Sodium Chloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Micafungin in Sodium Chloride", "active_ingredients": [{"name": "MICAFUNGIN SODIUM", "strength": "100 mg/100mL"}], "application_number": "NDA216142", "marketing_category": "NDA", "marketing_start_date": "20230929", "listing_expiration_date": "20261231"}