Home NDC 0904-6596 voriconazole
Product NDC 0904-6596
11-digit product format 009046596
Labeler code 0904
Product ID 0904-6596_af2892fb-c3b7-45ea-93b8-ecf45fe057fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA206747
Marketing category ANDA
Marketing start 2016-05-25
Substance VORICONAZOLE
Active strength 50 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 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 A206747-001 VORICONAZOLE VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 A206747-002 VORICONAZOLE VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24
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 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 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 50 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0904-6596-04 voriconazole 30 in 1 CARTON TABLET, FILM COATED 30 9 0904-6596-04 voriconazole 1 in 1 BLISTER PACK TABLET, FILM COATED 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6596 VORICONAZOLE TABLET [MAJOR PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 2 package rows 20250402_49dcf3ae-6d6b-46fe-a88e-ec65f2de332e.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 0904-6596-04 00904659604 30 BLISTER PACK in 1 CARTON (0904-6596-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2016-05-25 0000-00-00 No No Current