Home NDC 67184-0590 MICAFUNGIN
Product NDC 67184-0590
11-digit product format 671840590
Labeler code 67184
Product ID 67184-0590_0f106cca-1588-4f13-a833-662676fc85c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Qilu Pharmaceutical Co., Ltd
Application ANDA219273
Marketing category ANDA
Marketing start 2025-04-03
Substance MICAFUNGIN
Active strength 20 mg/mL
Pharmacologic classes Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219273-001 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 A219273-002 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MICAFUNGIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICAFUNGIN 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R10H71BSWG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861379 Internal RxNorm lookup 861383 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67184-0590-1 67184059001 1 VIAL in 1 CARTON (67184-0590-1) / 5 mL in 1 VIAL 1 vial 2025-04-03 No No Current 67184-0590-2 67184059002 10 VIAL in 1 CARTON (67184-0590-2) / 5 mL in 1 VIAL 10 vial 2025-04-03 No No Current