voriconazole

Product NDC
68382-736
11-digit product format
683820736
Labeler code
68382
Product ID
68382-736_68703f91-9a34-462b-9386-65c189581b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA206747
Marketing category
ANDA
Marketing start
2016-05-25
Marketing end
2020-08-01
Substance
VORICONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-736DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-01DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-05DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-06DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-10DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-16DDiscontinued by firm2026-08-17
excluded packagepackage68382-73668382-736-77DDiscontinued 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 2 · 84 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 packagepackage68382-736-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-736-77d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-736-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-736-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-736-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-736-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-77f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-736-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-772ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-736-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-77a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-736-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-77cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-16cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-736-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-77cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-16cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-736-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-77302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-16302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-736-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-77ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-16ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-736-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-736-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-736-770efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68382-736-060efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206747-001VORICONAZOLEVORICONAZOLE50MGTABLET / ORALAB2016-05-24
A206747-002VORICONAZOLEVORICONAZOLE200MGTABLET / ORALAB2016-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206747-001AB
A206747-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206747-001VORICONAZOLE50MGTABLET / ORALAB2016-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206747-002VORICONAZOLE200MGTABLET / ORALAB2016-05-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206747-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206747-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206747-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206747-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206747-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206747-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206747-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206747-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206747-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206747-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206747-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206747-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206747-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206747-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206747-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206747-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206747-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206747-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206747-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206747-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206747-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206747-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206747-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206747-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206747-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206747-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206747-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206747-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206747-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206747-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206747-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206747-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206747-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206747-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206747-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206747-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206747-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206747-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206747-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206747-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-736-06EA - Each68382-7363d05000c-2ce4-4ac7-b38b-eb5fc4d4c5b012016-07-19

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
voriconazoleVORICONAZOLEMajor Pharmaceuticals49dcf3ae-6d6b-46fe-a88e-ec65f2de332e2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206747
application number: ANDA206747
voriconazoleVORICONAZOLEViona Pharmaceuticals Inc75fcbea8-8eeb-4528-b7d9-a059dd25da832026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206747
application number: ANDA206747
voriconazoleVORICONAZOLEZydus Lifesciences Limitedbda70104-d84b-4d3f-9ca0-5f4f1ca816ad2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206747
application number: ANDA206747