Home NDC 0469-3250-50 Mycamine
Product NDC 0469-3250
Requested package NDC 0469-3250-50
11-digit product format 004693250
Labeler code 0469
Product ID 0469-3250_9c5e9ccb-1ded-4c6a-8781-4d25e6f41299
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Astellas Pharma US, Inc.
Application NDA021506
Marketing category NDA
Marketing start 2005-03-16
Marketing end 2026-09-30
Substance MICAFUNGIN SODIUM
Active strength 10 mg/mL
Pharmacologic classes Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021506-002 MYCAMINE MICAFUNGIN SODIUM EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-16 N021506-003 MYCAMINE MICAFUNGIN SODIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-06-27
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 3 · 82 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 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2006-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2006-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 79 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021506-002 6107458 2019-03-16 U-845 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6107458 2019-03-16 U-650 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 U-650 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104 2021-01-08 U-845 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-002 6774104*PED 2021-07-08 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6107458 2019-03-16 U-845 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6107458 2019-03-16 U-650 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 Drug product 2013-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 U-650 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104 2021-01-08 U-845 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021506-003 6774104*PED 2021-07-08 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021506-002 6774104 2021-01-08 U-650 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-002 6774104 2021-01-08 U-845 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-002 6774104*PED 2021-07-08 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-003 6774104 2021-01-08 U-845 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-003 6774104 2021-01-08 U-650 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021506-003 6774104*PED 2021-07-08 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-002 6774104 2021-01-08 U-650 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-002 6774104 2021-01-08 U-845 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-002 6774104*PED 2021-07-08 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-003 6774104 2021-01-08 U-845 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-003 6774104 2021-01-08 U-650 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021506-003 6774104*PED 2021-07-08 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021506-002 6774104 2021-01-08 U-650 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021506-002 6774104 2021-01-08 U-845 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021506-002 6774104*PED 2021-07-08 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021506-003 6774104 2021-01-08 U-845 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021506-003 6774104 2021-01-08 U-650 Drug product 5aa47cf7b7d7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mycamine Active Ingredients# Ingredient, Strength table Ingredient Strength MICAFUNGIN SODIUM 10 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861379 Internal RxNorm lookup 861381 Internal RxNorm lookup 861383 Internal RxNorm lookup 861385 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 0469-3250-10 Mycamine 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 19 0469-3250-10 Mycamine 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MICAFUNGIN SODIUM ACTIVE INGREDIENT IS1UP79R56 MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 9 MICAFUNGIN ACTIVE MOIETY R10H71BSWG MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-3250 MYCAMINE (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20250101_a064c4a7-25ec-4a2c-afc2-703491a4a38b.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 0469-3250-50 00469325050 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3250-50) > 5 mL in 1 VIAL, SINGLE-DOSE 2014-12-01 0000-00-00 No No Current