Home NDC 70594-037-01 Micafungin
Product NDC 70594-037
Requested package NDC 70594-037-01
11-digit product format 705940037
Labeler code 70594
Product ID 70594-037_8914e314-98a8-4461-8b86-2fe36b41f9ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin Sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA211713
Marketing category ANDA
Marketing start 2021-06-02
Marketing end 0000-00-00
Substance MICAFUNGIN SODIUM
Active strength 20 mg/mL
Pharmacologic classes Echinocandin Antifungal [EPC],Lipopeptides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 A211713-001 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 A211713-002 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02
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.
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 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211713-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211713-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2021-06-02 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-037 MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 13 Legacy NDC 20231201_3bc8668e-8ec3-4c54-b46b-5ca0dac87c1b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70594-037-01 70594003701 1 VIAL, GLASS in 1 CARTON (70594-037-01) > 5 mL in 1 VIAL, GLASS 2021-06-02 0000-00-00 No No Current