Home NDC 70771-1683 Micafungin
Product NDC 70771-1683
11-digit product format 707711683
Labeler code 70771
Product ID 70771-1683_6d0bfa2b-cc2e-4759-988c-543631badfa4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Zydus Lifesciences Limited
Application ANDA215241
Marketing category ANDA
Marketing start 2023-04-10
Substance MICAFUNGIN SODIUM
Active strength 10 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 A215241-001 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 A215241-002 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24
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 · 50 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 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215241-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS 2022-10-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215241-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS 2022-10-24 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Micafungin
Listing expiration 2026-12-31 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 · 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 70771-1683-1 Micafungin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3 70771-1683-1 Micafungin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 3 70771-1683-6 Micafungin 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 3 70771-1683-6 Micafungin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1683 MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED] 2 Current NDC, 4 package rows 20240918_72bc5dd6-6052-4483-9b13-afdeaaa8cc69.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 · 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 70771-1683-1 70771168301 1 VIAL in 1 CARTON (70771-1683-1) / 5 mL in 1 VIAL 1 vial 2024-08-20 No No Current 70771-1683-6 70771168306 10 VIAL in 1 CARTON (70771-1683-6) / 5 mL in 1 VIAL 10 vial 2023-04-10 No No Current