voriconazole

Product NDC
63739-707
11-digit product format
637390707
Labeler code
63739
Product ID
63739-707_f0dc2ec5-24e1-4191-bb7c-a5d9c607d26e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA200265
Marketing category
ANDA
Marketing start
2011-12-12
Marketing end
0000-00-00
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
2021-12-31
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 productproduct63739-707DDiscontinued by firm2026-08-17
excluded packagepackage63739-70763739-707-33DDiscontinued 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 · 24 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 packagepackage63739-707-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-707-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-707-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-707-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-707-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-707-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-707-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-707-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-707-330efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-707-33ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-707-33367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-707-33557ba5c1ecfa…9c80585c8c6e…

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
A200265-001VORICONAZOLEVORICONAZOLE50MGTABLET / ORALAB2011-12-12
A200265-002VORICONAZOLEVORICONAZOLE200MGTABLET / ORALAB2011-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200265-001AB
A200265-002AB

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 06:07:402026-07A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12caaa826d4ba7…
2026-08-18 06:07:402026-07A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12bb7c543d1eb4…

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 06:07:402026-07A200265-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200265-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200265-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200265-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200265-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200265-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200265-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200265-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200265-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200265-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200265-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200265-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200265-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200265-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200265-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200265-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200265-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200265-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200265-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200265-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200265-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200265-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200265-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200265-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200265-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200265-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200265-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200265-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200265-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200265-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200265-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200265-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200265-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200265-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200265-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200265-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200265-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200265-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200265-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200265-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-707-33EA - Each63739-707b2134282-2606-4c42-8418-44a7ce39d84712015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORICONAZOLEACTIVE INGREDIENTJFU09I87TRVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
VORICONAZOLEACTIVE MOIETYJFU09I87TRVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TRIACETININACTIVE INGREDIENTXHX3C3X673VORICONAZOLE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
voriconazoleVORICONAZOLESandoz Ince2b3c0b3-02a6-45c3-a8ea-05d210dc91082026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200265
application number: ANDA200265
voriconazoleVORICONAZOLEBryant Ranch Prepack8217c621-976e-450b-8f48-5dc3119dc53c2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200265
application number: ANDA200265
voriconazoleVORICONAZOLEBryant Ranch Prepack35098192-3bcb-9111-e063-6394a90ae8ea2025-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200265
application number: ANDA200265
voriconazoleVORICONAZOLEBryant Ranch Prepack711e5a1b-8c40-4b18-9f4f-12c8ab3510122024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200265
application number: ANDA200265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-707-33637390707333 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-707-33) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2015-03-120000-00-00NoNoCurrent