Micafungin

Product NDC
70594-036
11-digit product format
705940036
Labeler code
70594
Product ID
70594-036_8914e314-98a8-4461-8b86-2fe36b41f9ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA211713
Marketing category
ANDA
Marketing start
2021-06-02
Marketing end
0000-00-00
Substance
MICAFUNGIN SODIUM
Active strength
10 mg/mL
Pharmacologic classes
Echinocandin Antifungal [EPC],Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70594-036-012021-06-11C16284748780-1ba0f9c33-3408-a910-e053-dadaa90a0b853bc8668e-8ec3-4c54-b46b-5ca0dac87c1b
70594-036-012021-01-29C16284748780-1ba0f9c33-3408-a910-e053-dadaa90a0b853bc8668e-8ec3-4c54-b46b-5ca0dac87c1b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-036-01EA - Each70594-036c909dc08-4235-4ec3-a248-3bb34bdfc26512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-036MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]13Legacy NDC20231201_3bc8668e-8ec3-4c54-b46b-5ca0dac87c1b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70594-036-01705940036011 VIAL, GLASS in 1 CARTON (70594-036-01) > 5 mL in 1 VIAL, GLASS2021-06-020000-00-00NoNoCurrent