Micafungin

Product NDC
16714-164
11-digit product format
167140164
Labeler code
16714
Product ID
16714-164_b46cbce8-c015-4ccf-ac66-c54d0e11c9da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Micafungin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Northstar Rx LLC.
Application
ANDA215241
Marketing category
ANDA
Marketing start
2022-11-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-164-01EA - Each16714-164560e5a9e-812e-4d34-a7de-fef6f7494ead12023-10-16
16714-164-10EA - Each16714-164bbf9bc33-9296-4da9-ae78-0bbf3d7590f512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-164MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC.]3Legacy NDC20241225_9f4e9192-cb74-4018-90a2-69f9f21dd667.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-164-101671401641010 VIAL in 1 CARTON (16714-164-10) > 5 mL in 1 VIAL (16714-164-01) 10 vial2022-11-010000-00-00NoNoCurrent