Home NDC 59762-0935 Voriconazole
Product NDC 59762-0935
11-digit product format 597620935
Labeler code 59762
Product ID 59762-0935_ab7497d0-3117-4060-ad3c-8ef321979949
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021630
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-12-16
Substance VORICONAZOLE
Active strength 40 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021630-001 VFEND VORICONAZOLE 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021630-001 AB
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 2 · 41 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 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021630-001 VFEND 200MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 2003-12-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Voriconazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORICONAZOLE 40 mg/mL
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 465355 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 59762-0935-3 Voriconazole 1 in 1 CARTON POWDER, FOR SUSPENSION 1 61 59762-0935-3 Voriconazole 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 61
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 59762-0935 VORICONAZOLE POWDER, FOR SUSPENSION VORICONAZOLE TABLET, FILM COATED [GREENSTONE LLC] 57 Current NDC, Legacy NDC, 2 package rows 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-0935-3 59762093503 1 BOTTLE in 1 CARTON (59762-0935-3) / 75 mL in 1 BOTTLE 1 bottle 2013-12-16 0000-00-00 No No Current