Home NDC 42658-023-01 Micafungin
Product NDC 42658-023
Requested package NDC 42658-023-01
11-digit product format 426580023
Labeler code 42658
Product ID 42658-023_4f4d74bd-7d4e-0340-e063-6394a90aee8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA219712
Marketing category ANDA
Marketing start 2026-04-01
Substance MICAFUNGIN SODIUM
Active strength 100 mg/1
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 A219712-001 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21 A219712-002 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21
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 A219712-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219712-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219712-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219712-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2026-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219712-001 AP 1 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219712-002 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219712-001 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219712-002 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Micafungin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICAFUNGIN SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IS1UP79R56 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42658-023-01 Micafungin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 6 42658-023-01 Micafungin 1 in 1 BOX, UNIT-DOSE INJECTION, POWDER, FOR SOLUTION 1 6 42658-023-02 Micafungin 1 in 1 BOX INJECTION, POWDER, FOR SOLUTION 1 6 42658-023-02 Micafungin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 6
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 · 1 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 42658-023-01 42658002301 1 VIAL in 1 BOX, UNIT-DOSE (42658-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 1 vial 2026-04-01 No No Current