NDC 70594-037

Micafungin

Micafungin Sodium

Micafungin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Xellia Pharmaceuticals Usa Llc. The primary component is Micafungin Sodium.

Product ID70594-037_8914e314-98a8-4461-8b86-2fe36b41f9ce
NDC70594-037
Product TypeHuman Prescription Drug
Proprietary NameMicafungin
Generic NameMicafungin Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-06-02
Marketing CategoryANDA /
Application NumberANDA211713
Labeler NameXellia Pharmaceuticals USA LLC
Substance NameMICAFUNGIN SODIUM
Active Ingredient Strength20 mg/mL
Pharm ClassesEchinocandin Antifungal [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70594-037-01

1 VIAL, GLASS in 1 CARTON (70594-037-01) > 5 mL in 1 VIAL, GLASS
Marketing Start Date2021-06-02
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0143-9361MicafunginMicafungin sodium
0143-9362MicafunginMicafungin sodium
16714-164MicafunginMicafungin
16714-301MicafunginMicafungin
25021-190MicafunginMicafungin Sodium
25021-191MicafunginMicafungin Sodium
42023-229MicafunginMicafungin
42023-230MicafunginMicafungin
60505-6119MicafunginMicafungin
60505-6120MicafunginMicafungin
63323-728MicafunginMicafungin Sodium
63323-729MicafunginMicafungin Sodium
70594-036MicafunginMicafungin Sodium
70594-037MicafunginMicafungin Sodium
71288-028MicafunginMicafungin sodium
71288-029MicafunginMicafungin sodium
72572-427MicafunginMicafungin sodium
0469-3211MycamineMicafungin Sodium
0469-3250MycamineMicafungin Sodium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.