Home NDC 42023-230 Micafungin
Product NDC 42023-230
11-digit product format 420230230
Labeler code 42023
Product ID 42023-230_9e300655-e1cc-4f04-9a9e-9b81688368dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application NDA212156
Marketing category NDA
Marketing start 2021-08-01
Substance MICAFUNGIN SODIUM
Active strength 20 mg/mL
Pharmacologic classes Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 N212156-001 MICAFUNGIN MICAFUNGIN SODIUM EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 N212156-002 MICAFUNGIN MICAFUNGIN SODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16
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.
Product history page 1 of 2 · 66 observed 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 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212156-001 MICAFUNGIN EQ 50MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212156-002 MICAFUNGIN EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-06-16 6a51e52b5d6a…
Additional Listing Data#
Finished product Yes
Brand name base Micafungin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICAFUNGIN SODIUM 20 mg/mL
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 42023-230-10 Micafungin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 13 42023-230-10 Micafungin 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-230 MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20240915_70b3f044-95ca-4503-b669-ed39972592b6.zip
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 Marketing start Marketing end Sample Exclude flag Status 42023-230-10 42023023010 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2021-08-01 0000-00-00 No No Current