Voriconazole

Product NDC
16714-199
11-digit product format
167140199
Labeler code
16714
Product ID
16714-199_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA206837
Marketing category
ANDA
Marketing start
2016-01-22
Marketing end
2027-04-30
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
16714-199-01Voriconazole30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-199-01EA - Each16714-199254359e7-991b-472d-b1db-6e343985408312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-199VORICONAZOLE TABLET, FILM COATED [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 1 package rows20250503_b38165a5-d8d4-4579-a49a-fbe92e764089.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSNb38165a5-d8d4-4579-a49a-fbe92e7640896
349435voriconazole 50 MG Oral TabletPSNb38165a5-d8d4-4579-a49a-fbe92e7640896
349434voriconazole 200 MG Oral TabletSCDb38165a5-d8d4-4579-a49a-fbe92e7640896
349435voriconazole 50 MG Oral TabletSCDb38165a5-d8d4-4579-a49a-fbe92e7640896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-199-011671401990130 TABLET, FILM COATED in 1 BOTTLE (16714-199-01) 2016-01-222027-04-30NoNoCurrent