Voriconazole

Product NDC
65862-891
11-digit product format
658620891
Labeler code
65862
Product ID
65862-891_3182e52d-c1d5-4af5-8081-cf382176638f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206837
Marketing category
ANDA
Marketing start
2016-01-22
Substance
VORICONAZOLE
Active strength
50 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Voriconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui349434, 349435

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
65862-891-01Voriconazole100 in 1 BOTTLETABLET, FILM COATED10017
65862-891-03Voriconazole3 in 1 CARTONTABLET, FILM COATED317
65862-891-05Voriconazole500 in 1 BOTTLETABLET, FILM COATED50017
65862-891-10Voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED1017
65862-891-30Voriconazole30 in 1 BOTTLETABLET, FILM COATED3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-891-30EA - Each65862-891e483e478-81de-40d8-ad78-7cbd589ffc6612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-891VORICONAZOLE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 5 package rows20250510_4fe672ff-2cef-4f88-ab85-5a4b586da20d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN4fe672ff-2cef-4f88-ab85-5a4b586da20d17
349435voriconazole 50 MG Oral TabletPSN4fe672ff-2cef-4f88-ab85-5a4b586da20d17
349434voriconazole 200 MG Oral TabletSCD4fe672ff-2cef-4f88-ab85-5a4b586da20d17
349435voriconazole 50 MG Oral TabletSCD4fe672ff-2cef-4f88-ab85-5a4b586da20d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-891-0165862089101100 TABLET, FILM COATED in 1 BOTTLE (65862-891-01) 2016-01-220000-00-00NoNoCurrent
65862-891-03658620891033 BLISTER PACK in 1 CARTON (65862-891-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-891-10) 3 blister pack2016-01-220000-00-00NoNoCurrent
65862-891-0565862089105500 TABLET, FILM COATED in 1 BOTTLE (65862-891-05) 2016-01-220000-00-00NoNoCurrent
65862-891-106586208911010 in 1 BLISTER PACKHistorical
65862-891-306586208913030 TABLET, FILM COATED in 1 BOTTLE (65862-891-30) 2016-01-220000-00-00NoNoCurrent