FDA.reportPublic FDA data

Voriconazole

Product NDC
50268-803
11-digit product format
502680803
Labeler code
50268
Product ID
50268-803_2b4d4596-5ea1-cb1d-e063-6394a90ab8dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA206654
Marketing category
ANDA
Marketing start
2022-08-19
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
50268-803-11Voriconazole1 in 1 BLISTER PACKTABLET, COATED12
50268-803-12Voriconazole20 in 1 BOXTABLET, COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-803-11EA - Each50268-8037ad92b4c-4987-460a-846c-9962229dfe5112022-09-12
50268-803-12EA - Each50268-80348551d50-4a40-4e95-82ed-c2a258a70d3612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-803VORICONAZOLE TABLET, COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20250112_e698e5c7-f4a5-2beb-e053-2995a90a256b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSNe698e5c7-f4a5-2beb-e053-2995a90a256b2
349434voriconazole 200 MG Oral TabletSCDe698e5c7-f4a5-2beb-e053-2995a90a256b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-803-11502680803111 in 1 BLISTER PACKHistorical
50268-803-125026808031220 BLISTER PACK in 1 BOX (50268-803-12) / 1 TABLET, COATED in 1 BLISTER PACK (50268-803-11) 20 blister pack2022-08-190000-00-00NoNoCurrent