NDC 63323-728

Micafungin

Micafungin Sodium

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

Product ID63323-728_6b2b3475-f97c-4400-99af-9efeb9a0f180
NDC63323-728
Product TypeHuman Prescription Drug
Proprietary NameMicafungin
Generic NameMicafungin Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA207344
Labeler NameFresenius Kabi USA, LLC
Substance NameMICAFUNGIN SODIUM
Active Ingredient Strength50 mg/1
Pharm ClassesEchinocandin Antifungal [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-728-10

10 CARTON in 1 CARTON (63323-728-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-728-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-728-01 [63323072801]

Micafungin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207344
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-05-08

NDC 63323-728-10 [63323072810]

Micafungin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207344
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-05-08

Drug Details

Active Ingredients

IngredientStrength
MICAFUNGIN SODIUM50 mg/1

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
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