Home NDC 0781-5668 voriconazole
Product NDC 0781-5668
11-digit product format 007815668
Labeler code 0781
Product ID 0781-5668_efbbf86a-b798-4963-8786-0d7033ee908b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA200265
Marketing category ANDA
Marketing start 2011-12-12
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 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 A200265-001 VORICONAZOLE VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 A200265-002 VORICONAZOLE VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12
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 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200265-001 VORICONAZOLE 50MG TABLET / ORAL AB 2011-12-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200265-002 VORICONAZOLE 200MG TABLET / ORAL AB 2011-12-12 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 0781-5668-05 voriconazole 500 in 1 BOTTLE TABLET, FILM COATED 500 23 0781-5668-06 voriconazole 10 in 1 BLISTER PACK TABLET, FILM COATED 10 23 0781-5668-10 voriconazole 1000 in 1 BOTTLE TABLET, FILM COATED 1000 23 0781-5668-13 voriconazole 10 in 1 CARTON TABLET, FILM COATED 10 23 0781-5668-31 voriconazole 30 in 1 BOTTLE TABLET, FILM COATED 30 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 11 VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5668 VORICONAZOLE TABLET, FILM COATED [SANDOZ INC] 21 Current NDC, Legacy NDC, 5 package rows 20250522_e2b3c0b3-02a6-45c3-a8ea-05d210dc9108.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 · 4 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 0781-5668-05 00781566805 500 TABLET, FILM COATED in 1 BOTTLE (0781-5668-05) 2011-12-12 0000-00-00 No No Current 0781-5668-06 00781566806 10 in 1 BLISTER PACK Historical 0781-5668-10 00781566810 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5668-10) 2011-12-12 0000-00-00 No No Current 0781-5668-13 00781566813 10 BLISTER PACK in 1 CARTON (0781-5668-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5668-06) 10 blister pack 2011-12-12 0000-00-00 No No Current 0781-5668-31 00781566831 30 TABLET, FILM COATED in 1 BOTTLE (0781-5668-31) 2011-12-12 0000-00-00 No No Current