Home NDC 0378-1640 Voriconazole
Product NDC 0378-1640
11-digit product format 003781640
Labeler code 0378
Product ID 0378-1640_4648d2c0-408b-4d93-99a1-627b428a89cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090547
Marketing category ANDA
Marketing start 2011-02-15
Substance VORICONAZOLE
Active strength 200 mg/1
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 2027-12-31
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 · 4 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 2025-01-20 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 0378-1640-93 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 0378-1640-93 0efc9e666f02…f202fb6c5f17…
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 A090547-001 VORICONAZOLE VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 A090547-002 VORICONAZOLE VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22
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 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090547-001 VORICONAZOLE 50MG TABLET / ORAL AB 2010-04-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090547-002 VORICONAZOLE 200MG TABLET / ORAL AB 2010-04-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Voriconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 200 mg/1
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 349434 Internal RxNorm lookup 349435 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 0378-1640-93 Voriconazole 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 POVIDONES INACTIVE INGREDIENT FZ989GH94E VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1640 VORICONAZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 25 Current NDC, Legacy NDC, 1 package rows 20250124_67c174da-41b8-4738-8a22-dd814b8e96b8.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 Marketing start Marketing end Sample Exclude flag Status 0378-1640-93 00378164093 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1640-93) 2011-02-15 0000-00-00 No No Current