voriconazole

Product NDC
71335-2911
11-digit product format
713352911
Labeler code
71335
Product ID
71335-2911_098ae684-783c-4cf1-9126-146e1d462b22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200265
Marketing category
ANDA
Marketing start
2011-12-12
Substance
VORICONAZOLE
Active strength
200 mg/1
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
2026-12-31
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 · 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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A200265-001VORICONAZOLE50MGTABLET / ORALAB2011-12-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A200265-002VORICONAZOLE200MGTABLET / ORALAB2011-12-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A200265-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200265-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
voriconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JFU09I87TRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8217c621-976e-450b-8f48-5dc3119dc53cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2911-1voriconazole30 in 1 BOTTLETABLET, FILM COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2911-1EA - Each71335-291162373d73-6651-4009-8e5a-e50e91f5524812025-12-16

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
ndc (product): 71335-2911
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN8217c621-976e-450b-8f48-5dc3119dc53c100
349434voriconazole 200 MG Oral TabletSCD8217c621-976e-450b-8f48-5dc3119dc53c100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2911-17133529110130 TABLET, FILM COATED in 1 BOTTLE (71335-2911-1) 2025-10-21NoNoCurrent