voriconazole

Product NDC
63629-8734
11-digit product format
636298734
Labeler code
63629
Product ID
63629-8734_d7d66c66-0efb-4ad0-9245-2ed7790b0e0a
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

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 Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui349434

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
63629-8734-1voriconazole30 in 1 BOTTLETABLET, FILM COATED30107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8734VORICONAZOLE TABLET, FILM COATED [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240807_711e5a1b-8c40-4b18-9f4f-12c8ab351012.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN711e5a1b-8c40-4b18-9f4f-12c8ab351012107
349434voriconazole 200 MG Oral TabletSCD711e5a1b-8c40-4b18-9f4f-12c8ab351012107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8734-16362987340130 TABLET, FILM COATED in 1 BOTTLE (63629-8734-1) 2011-12-120000-00-00NoNoCurrent