Home NDC 55150-321 Voriconazole
Product NDC 55150-321
11-digit product format 551500321
Labeler code 55150
Product ID 55150-321_13107b7f-40e5-4e02-99e7-74469a806b3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA212162
Marketing category ANDA
Marketing start 2023-02-02
Substance VORICONAZOLE
Active strength 10 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212162-001 VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS 2023-02-02
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 A212162-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS 2023-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212162-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS 2023-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS 2023-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2023-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2023-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212162-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2023-02-02 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212162-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS 2023-02-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212162-001 AP 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212162-001 AP 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212162-001 AP 1 053a50430f4f…
Additional Listing Data#
Finished product Yes
Brand name base Voriconazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JFU09I87TR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351209 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 55150-321-01 Voriconazole 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 2 55150-321-01 Voriconazole 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-321 VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 2 Current NDC, 2 package rows 20240308_171272c7-d76e-4352-81bc-fcb40386d7d0.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 Sample Exclude flag Status 55150-321-01 55150032101 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-321-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2023-02-02 No No Current