FDA.reportPublic FDA data

Voriconazole

Product NDC
31722-266
11-digit product format
317220266
Labeler code
31722
Product ID
31722-266_3dcdfac8-4e3e-cf25-e063-6294a90a1366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211598
Marketing category
ANDA
Marketing start
2025-08-08
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
A211598-001VORICONAZOLEVORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2025-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211598-001AB

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 UTC2026-02A211598-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2025-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211598-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2025-08-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211598-001VORICONAZOLE200MG/5MLFOR SUSPENSION / ORALAB2025-08-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211598-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211598-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211598-001AB1a50c72e98297…

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
fceb92c5-5269-46e2-ac5f-547b2f77953dAvailable 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
31722-266-31Voriconazole75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION751
31722-266-31Voriconazole1 in 1 CARTONPOWDER, FOR SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-266-31ML - Milliliter31722-2664c14d59f-d52d-424b-bf73-c598623b487412026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VoriconazoleVORICONAZOLECamber Pharmaceuticals, Inc.fceb92c5-5269-46e2-ac5f-547b2f77953d2025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211598
application number: ANDA211598
ndc (product): 31722-266

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465355voriconazole 40 MG in 1 mL Oral SuspensionPSNfceb92c5-5269-46e2-ac5f-547b2f77953d1
465355voriconazole 40 MG/ML Oral SuspensionSCDfceb92c5-5269-46e2-ac5f-547b2f77953d1
465355voriconazole 200 MG/5 ML Oral SuspensionSYfceb92c5-5269-46e2-ac5f-547b2f77953d1
465355voriconazole 40 MG per 1 ML Oral SuspensionSYfceb92c5-5269-46e2-ac5f-547b2f77953d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-266-31317220266311 BOTTLE in 1 CARTON (31722-266-31) / 75 mL in 1 BOTTLE1 bottle2025-08-08NoNoCurrent