Home NDC 68462-772 MICAFUNGIN
Product NDC 68462-772
11-digit product format 684620772
Labeler code 68462
Product ID 68462-772_31e74606-bccd-4276-bb20-a1933ce4ca25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Micafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA219273
Marketing category ANDA
Marketing start 2025-06-30
Substance MICAFUNGIN
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 A219273-001 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 A219273-002 MICAFUNGIN SODIUM MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03
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 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219273-001 MICAFUNGIN SODIUM EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219273-002 MICAFUNGIN SODIUM EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-04-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MICAFUNGIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICAFUNGIN 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R10H71BSWG 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 68462-772-01 MICAFUNGIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 68462-772-01 MICAFUNGIN 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 1 68462-772-10 MICAFUNGIN 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 1 68462-772-10 MICAFUNGIN 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 1
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 68462-772-01 68462077201 1 VIAL in 1 CARTON (68462-772-01) / 5 mL in 1 VIAL 1 vial 2025-06-30 No No Current 68462-772-10 68462077210 10 VIAL in 1 CARTON (68462-772-10) / 5 mL in 1 VIAL 10 vial 2025-06-30 No No Current