voriconazole

Product NDC
72673-111
11-digit product format
726730111
Labeler code
72673
Product ID
72673-111_32669bf5-b300-fb86-e063-6394a90a02a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zhejiang Poly Pharm Co., Ltd.
Application
ANDA216805
Marketing category
ANDA
Marketing start
2025-04-11
Substance
VORICONAZOLE
Active strength
40 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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216805-001VORICONAZOLEVORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216805-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-028072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-021c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216805-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2024-01-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216805-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216805-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216805-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216805-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216805-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216805-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216805-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216805-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216805-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216805-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216805-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216805-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216805-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216805-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216805-001AB11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216805-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE40 mg/mL

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
465355Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3266cf9b-e648-1ff2-e063-6394a90a0487Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72673-111-30voriconazole75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION752
72673-111-30voriconazole1 in 1 CARTONPOWDER, FOR SUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72673-111VORICONAZOLE POWDER, FOR SUSPENSION [ZHEJIANG POLY PHARM CO., LTD.]2Current NDC, 2 package rows20250411_3266cf9b-e648-1ff2-e063-6394a90a0487.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
voriconazoleVORICONAZOLESlate Run Pharmaceuticals, LLC2b262849-9a29-44a2-9b9d-2378f771379c2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216805
application number: ANDA216805
voriconazoleVORICONAZOLEZhejiang Poly Pharm Co., Ltd.3266cf9b-e648-1ff2-e063-6394a90a04872025-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216805
application number: ANDA216805
ndc (product): 72673-111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465355voriconazole 40 MG in 1 mL Oral SuspensionPSN3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 40 MG/ML Oral SuspensionSCD3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 200 MG/5 ML Oral SuspensionSY3266cf9b-e648-1ff2-e063-6394a90a04872
465355voriconazole 40 MG per 1 ML Oral SuspensionSY3266cf9b-e648-1ff2-e063-6394a90a04872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72673-111-30726730111301 BOTTLE in 1 CARTON (72673-111-30) / 75 mL in 1 BOTTLE1 bottle2025-04-11NoNoCurrent