Home NDC 0781-3416 Voriconazole
Product NDC 0781-3416
11-digit product format 007813416
Labeler code 0781
Product ID 0781-3416_aef09a5b-01be-4649-a0d7-fe7c187c8ce1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voriconazole
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA090862
Marketing category ANDA
Marketing start 2012-05-30
Substance VORICONAZOLE
Active strength 10 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 A090862-001 VORICONAZOLE VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2012-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090862-001 AP
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 A090862-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2012-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090862-001 VORICONAZOLE 200MG/VIAL POWDER / INTRAVENOUS AP 2012-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090862-001 VORICONAZOLE 200MG/VIAL INJECTABLE / INTRAVENOUS AP 2012-05-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 10 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 351209 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 0781-3416-94 Voriconazole 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 30 0781-3416-94 Voriconazole 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VORICONAZOLE ACTIVE INGREDIENT JFU09I87TR VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 16 VORICONAZOLE ACTIVE MOIETY JFU09I87TR VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 16 SULFOBUTYLETHER .BETA.-CYCLODEXTRIN INACTIVE INGREDIENT 2PP9364507 VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3416 VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 28 Current NDC, Legacy NDC, 2 package rows 20250519_e648a0e4-f324-49dc-a8f6-cf25ff3b2dfe.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 Marketing start Marketing end Sample Exclude flag Status 0781-3416-94 00781341694 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) / 20 mL in 1 VIAL, SINGLE-USE 2012-05-30 0000-00-00 No No Current