Home NDC 55154-2725 VFEND
Product NDC 55154-2725
11-digit product format 551542725
Labeler code 55154
Product ID 55154-2725_c9a9b2de-dae1-411c-a13e-8b445ff993ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health
Application NDA021266
Marketing category NDA
Marketing start 2002-05-24
Marketing end 0000-00-00
Substance VORICONAZOLE
Active strength 200 mg/1
Pharmacologic classes Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 37 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55154-2725-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55154-2725-4 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55154-2725-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55154-2725-4 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55154-2725-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55154-2725-4 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55154-2725-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55154-2725-4 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55154-2725-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55154-2725-4 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55154-2725-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55154-2725-4 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55154-2725-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55154-2725-4 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55154-2725-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55154-2725-4 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55154-2725-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55154-2725-4 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55154-2725-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55154-2725-4 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55154-2725-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55154-2725-4 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55154-2725-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55154-2725-4 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 N021266-001 VFEND VORICONAZOLE 50MG TABLET / ORAL AB RLD 2002-05-24 N021266-002 VFEND VORICONAZOLE 200MG TABLET / ORAL AB RLD, RS 2002-05-24
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 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 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded voriconazole ACTIVE INGREDIENT JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 voriconazole ACTIVE MOIETY JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 povidone INACTIVE INGREDIENT FZ989GH94E VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2 triacetin INACTIVE INGREDIENT XHX3C3X673 VFEND (VORICONAZOLE) TABLET, FILM COATED [CARDINAL HEALTH] 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VFEND VORICONAZOLE Roerig ce3ef5cf-3087-4d92-9d94-9eb8287228db 2026-02-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 021266 application number: NDA021266