NDC 0469-3250

Mycamine

Micafungin Sodium

Mycamine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Micafungin Sodium.

• Product ID: 0469-3250_3288a77d-441a-4db5-9759-30f228343a07
• NDC: 0469-3250
• Product Type: Human Prescription Drug
• Proprietary Name: Mycamine
• Generic Name: Micafungin Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA021506
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: MICAFUNGIN SODIUM
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Echinocandin Antifungal [EPC],Lipopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0469-3250-50

10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-50) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-3250-50 [00469325050]

Mycamine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021506
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-01

NDC 0469-3250-10 [00469325010]

Mycamine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021506
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-03-16

Drug Details

Active Ingredients

Ingredient	Strength
MICAFUNGIN SODIUM	10 mg/mL

OpenFDA Data

• SPL SET ID: a064c4a7-25ec-4a2c-afc2-703491a4a38b
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • IS1UP79R56
• RxNorm Concept Unique ID - RxCUI:
  • 861385
  • 861379
  • 861381
  • 861383

Pharmacological Class

• Echinocandin Antifungal [EPC]
• Lipopeptides [CS]

NDC Crossover Matching brand name "Mycamine" or generic name "Micafungin Sodium"

NDC	Brand Name	Generic Name
0469-3211	Mycamine	Micafungin Sodium
0469-3250	Mycamine	Micafungin Sodium
0143-9361	Micafungin	Micafungin sodium
0143-9362	Micafungin	Micafungin sodium
25021-190	Micafungin	Micafungin Sodium
25021-191	Micafungin	Micafungin Sodium
63323-728	Micafungin	Micafungin Sodium
63323-729	Micafungin	Micafungin Sodium
70594-036	Micafungin	Micafungin Sodium
70594-037	Micafungin	Micafungin Sodium
71288-028	Micafungin	Micafungin sodium
71288-029	Micafungin	Micafungin sodium
72572-427	Micafungin	Micafungin sodium