VORICONAZOLE

Product NDC
47781-466
11-digit product format
477810466
Labeler code
47781
Product ID
47781-466_22b99394-f31c-5a01-e206-965c0ece23b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VORICONAZOLE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA206398
Marketing category
ANDA
Marketing start
2016-08-08
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47781-466DDiscontinued by firm2026-08-17
excluded packagepackage47781-46647781-466-71DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47781-466-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47781-466-71f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206398-001VORICONAZOLEVORICONAZOLE200MG/VIALPOWDER / INTRAVENOUS2016-03-23

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206398-001VORICONAZOLE200MG/VIALPOWDER / INTRAVENOUS2016-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206398-001VORICONAZOLE200MG/VIALPOWDER / INTRAVENOUS2016-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206398-001VORICONAZOLE200MG/VIALPOWDER / INTRAVENOUSAP2016-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-233f01610625f2…
2019-09-15 20:21 UTC2019-09A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206398-001VORICONAZOLE200MG/VIALINJECTABLE / INTRAVENOUSAP2016-03-23e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206398-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206398-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206398-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206398-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206398-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206398-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206398-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206398-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206398-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206398-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206398-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206398-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206398-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206398-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206398-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206398-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206398-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206398-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206398-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206398-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A206398-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206398-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206398-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206398-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A206398-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206398-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206398-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206398-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206398-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206398-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206398-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206398-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206398-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206398-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206398-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206398-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206398-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206398-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206398-001AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-466-71EA - Each47781-4669aef9a34-7310-42df-8f79-d48255afaa2a12016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-466-71477810466711 VIAL in 1 CARTON (47781-466-71) > 20 mL in 1 VIAL1 vial2016-08-080000-00-00NoNoCurrent