FDA.reportPublic FDA data

Voriconazole

Product NDC
60687-294
11-digit product format
606870294
Labeler code
60687
Product ID
60687-294_3f173cc6-1846-9797-e063-6394a90ad8eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203503
Marketing category
ANDA
Marketing start
2018-03-07
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Voriconazole

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
60687-294-11Voriconazole1 in 1 BLISTER PACKTABLET, FILM COATED19
60687-294-21Voriconazole30 in 1 BOX, UNIT-DOSETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-294-11EA - Each60687-294016a3e68-03ba-44ef-83d6-f79e20a5949712018-04-19
60687-294-21EA - Each60687-294d15dc9f1-5a9b-491e-ab4a-01ce7f3a067112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-294VORICONAZOLE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240913_8379ac92-53cd-46db-8642-017f11830a86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
60687-294-11606870294111 in 1 BLISTER PACKHistorical
60687-294-216068702942130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-294-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-294-11) 30 blister pack2018-03-072026-06-30NoNoCurrent