voriconazole

Product NDC
68462-573
11-digit product format
684620573
Labeler code
68462
Product ID
68462-573_1c47b796-6b3e-4321-86f6-f51fbf9a39fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA203503
Marketing category
ANDA
Marketing start
2015-09-04
Marketing end
2027-01-01
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
voriconazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 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
68462-573-13voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED1017
68462-573-13voriconazole3 in 1 CARTONTABLET, FILM COATED317
68462-573-30voriconazole30 in 1 BOTTLETABLET, FILM COATED3017
68462-573-90voriconazole90 in 1 BOTTLETABLET, FILM COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-573-30EA - Each68462-573a1c742a5-ea92-4980-9298-1629c922e92f12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-573VORICONAZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]16Current NDC, Legacy NDC, 4 package rows20250418_4cbac6ad-0faa-4181-a830-27a9f1536b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN4cbac6ad-0faa-4181-a830-27a9f1536b7a17
349435voriconazole 50 MG Oral TabletPSN4cbac6ad-0faa-4181-a830-27a9f1536b7a17
349434voriconazole 200 MG Oral TabletSCD4cbac6ad-0faa-4181-a830-27a9f1536b7a17
349435voriconazole 50 MG Oral TabletSCD4cbac6ad-0faa-4181-a830-27a9f1536b7a17
349434voriconazole 200 MG Oral TabletPSN8379ac92-53cd-46db-8642-017f11830a869
349435voriconazole 50 MG Oral TabletPSN8379ac92-53cd-46db-8642-017f11830a869
349434voriconazole 200 MG Oral TabletSCD8379ac92-53cd-46db-8642-017f11830a869
349435voriconazole 50 MG Oral TabletSCD8379ac92-53cd-46db-8642-017f11830a869

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-573-13684620573133 BLISTER PACK in 1 CARTON (68462-573-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2015-09-042027-01-01NoNoCurrent
68462-573-306846205733030 TABLET, FILM COATED in 1 BOTTLE (68462-573-30) 2015-09-042027-01-01NoNoCurrent
68462-573-906846205739090 TABLET, FILM COATED in 1 BOTTLE (68462-573-90) 2015-09-042027-01-01NoNoCurrent