Home NDC 59762-0936 Voriconazole
Product NDC 59762-0936
11-digit product format 597620936
Labeler code 59762
Product ID 59762-0936_b21944f6-8755-4783-8906-9ba116f34d82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Greenstone LLC
Application NDA021266
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-06-05
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 2025-12-14 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 59762-0936-1 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 59762-0936-1 f5e01cc5f278…a2eaf40c39c3…
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 N021266-001 VFEND VORICONAZOLE 50MG TABLET / ORAL AB RLD 2002-05-24 N021266-002 VFEND VORICONAZOLE 200MG TABLET / ORAL AB RLD, RS 2002-05-24
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 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021266-001 VFEND 50MG TABLET / ORAL AB RLD 2002-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021266-002 VFEND 200MG TABLET / ORAL AB RLD, RS 2002-05-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book exclusivity history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VORICONAZOLE TABLET, FILM COATED VORICONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0936 VORICONAZOLE POWDER, FOR SUSPENSION VORICONAZOLE TABLET, FILM COATED [GREENSTONE LLC] 57 Legacy NDC 20250331_b8de04a0-238d-4e0b-b0d9-7f7878b149d4.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VFEND VORICONAZOLE Roerig ce3ef5cf-3087-4d92-9d94-9eb8287228db 2026-02-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 021266 application number: NDA021266
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59762-0936-1 59762093601 30 TABLET, FILM COATED in 1 BOTTLE (59762-0936-1) 2018-06-05 0000-00-00 No No Current