Home NDC 65841-831 voriconazole
Product NDC 65841-831
11-digit product format 658410831
Labeler code 65841
Product ID 65841-831_7666344f-3ba8-4a08-a828-65b846868dc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA206747
Marketing category ANDA
Marketing start 2016-05-25
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 42 .
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 · 84 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 A206747-001 VORICONAZOLE 50MG TABLET / ORAL AB 2016-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206747-002 VORICONAZOLE 200MG TABLET / ORAL AB 2016-05-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 65841-831-01 voriconazole 100 in 1 BOTTLE TABLET, FILM COATED 100 17 65841-831-05 voriconazole 500 in 1 BOTTLE TABLET, FILM COATED 500 17 65841-831-06 voriconazole 30 in 1 BOTTLE TABLET, FILM COATED 30 17 65841-831-10 voriconazole 1000 in 1 BOTTLE TABLET, FILM COATED 1000 17 65841-831-16 voriconazole 90 in 1 BOTTLE TABLET, FILM COATED 90 17 65841-831-30 voriconazole 10 in 1 BLISTER PACK TABLET, FILM COATED 10 17 65841-831-77 voriconazole 10 in 1 CARTON TABLET, FILM COATED 10 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-831 VORICONAZOLE TABLET [ZYDUS LIFESCIENCES LIMITED] 14 Current NDC, Legacy NDC, 7 package rows 20250430_bda70104-d84b-4d3f-9ca0-5f4f1ca816ad.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 65841-831-01 65841083101 100 TABLET, FILM COATED in 1 BOTTLE (65841-831-01) 2016-05-25 0000-00-00 No No Current 65841-831-05 65841083105 500 TABLET, FILM COATED in 1 BOTTLE (65841-831-05) 2016-05-25 0000-00-00 No No Current 65841-831-06 65841083106 30 TABLET, FILM COATED in 1 BOTTLE (65841-831-06) 2016-05-25 0000-00-00 No No Current 65841-831-10 65841083110 1000 TABLET, FILM COATED in 1 BOTTLE (65841-831-10) 2016-05-25 0000-00-00 No No Current 65841-831-16 65841083116 90 TABLET, FILM COATED in 1 BOTTLE (65841-831-16) 2016-05-25 0000-00-00 No No Current 65841-831-30 65841083130 10 in 1 BLISTER PACK Historical 65841-831-77 65841083177 10 BLISTER PACK in 1 CARTON (65841-831-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-831-30) 10 blister pack 2016-05-25 0000-00-00 No No Current