Home NDC 0049-3160 VFEND
Product NDC 0049-3160
11-digit product format 000493160
Labeler code 0049
Product ID 0049-3160_cf9f1b2e-eeb4-48bb-9f1a-c2b8d94dfbea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voriconazole
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Roerig
Application NDA021630
Marketing category NDA
Marketing start 2003-03-28
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 VFEND
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349434 Internal RxNorm lookup 349435 Internal RxNorm lookup 351209 Internal RxNorm lookup 352218 Internal RxNorm lookup 352219 Internal RxNorm lookup 352220 Internal RxNorm lookup 465355 Internal RxNorm lookup 546624 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 0049-3160-44 VFEND 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 58 0049-3160-44 VFEND 1 in 1 CARTON POWDER, FOR SUSPENSION 1 58
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 POVIDONES INACTIVE INGREDIENT FZ989GH94E VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SUCROSE INACTIVE INGREDIENT C151H8M554 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-3160 VFEND (VORICONAZOLE) TABLET, FILM COATED VFEND (VORICONAZOLE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION VFEND (VORICONAZOLE) POWDER, FOR SUSPENSION [ROERIG] 54 Current NDC, Legacy NDC, 2 package rows 20250323_ce3ef5cf-3087-4d92-9d94-9eb8287228db.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.
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 0049-3160-44 00049316044 1 BOTTLE in 1 CARTON (0049-3160-44) / 75 mL in 1 BOTTLE 1 bottle 2003-03-28 0000-00-00 No No Current