Home NDC 0049-3190 VFEND
Product NDC 0049-3190
11-digit product format 000493190
Labeler code 0049
Product ID 0049-3190_8b24199e-0319-4538-a971-19d5ac52fd35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Roerig
Application NDA021267
Marketing category NDA
Marketing start 2002-05-24
Marketing end 2027-11-30
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
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0049-3190-38 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0049-3190-38 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0049-3190-38 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0049-3190-38 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0049-3190-38 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0049-3190-38 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0049-3190-38 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0049-3190-38 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0049-3190-38 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0049-3190-38 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0049-3190-38 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0049-3190-38 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021267-001 VFEND VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2002-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021267-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 N021267-001 VFEND 200MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2002-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021267-001 VFEND 200MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2002-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021267-001 VFEND 200MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2002-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021267-001 VFEND 200MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2002-05-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VFEND 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351209 Internal RxNorm lookup 352220 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 0049-3190-28 VFEND 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 58 0049-3190-28 VFEND 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 20 58 0049-3190-01 VFEND 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 30 0049-3190-01 VFEND 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 POVIDONES INACTIVE INGREDIENT FZ989GH94E VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SUCROSE INACTIVE INGREDIENT C151H8M554 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 9 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 9 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 9 VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 6 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 6 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-3190 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 54 Current NDC, Legacy NDC, 2 package rows 20250323_ce3ef5cf-3087-4d92-9d94-9eb8287228db.zip 0049-3190 VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 27 Current NDC, Legacy NDC, 2 package rows 20250331_dac26bcd-7a59-401f-9f66-a0649767cece.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0049-3190-01 00049319001 1 VIAL, SINGLE-USE in 1 CARTON (0049-3190-01) / 20 mL in 1 VIAL, SINGLE-USE 2002-05-24 2027-11-30 No No Current 0049-3190-28 00049319028 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-3190-28) / 20 mL in 1 VIAL, SINGLE-DOSE 2003-03-28 0000-00-00 No No Current 0049-3190-38 00049319038 20 mL in 1 VIAL, SINGLE-USE (0049-3190-38) 20 ml 2012-10-24 0000-00-00 No No Current