FDA.reportPublic FDA data

Voriconazole

Product NDC
43547-378
11-digit product format
435470378
Labeler code
43547
Product ID
43547-378_50fab275-8f53-4dce-8c76-7c51fa170fcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA206654
Marketing category
ANDA
Marketing start
2016-10-28
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, 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
43547-378-03Voriconazole30 in 1 BOTTLETABLET, COATED308
43547-378-50Voriconazole500 in 1 BOTTLETABLET, COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-378-03EA - Each43547-37820f47668-0edf-46bb-b4ae-cfa5fe0774eb12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-378VORICONAZOLE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]4Current NDC, Legacy NDC, 2 package rows20210618_f6a1a792-141b-42e8-8bd1-884e4408eb8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSNf6a1a792-141b-42e8-8bd1-884e4408eb8a8
349435voriconazole 50 MG Oral TabletPSNf6a1a792-141b-42e8-8bd1-884e4408eb8a8
349434voriconazole 200 MG Oral TabletSCDf6a1a792-141b-42e8-8bd1-884e4408eb8a8
349435voriconazole 50 MG Oral TabletSCDf6a1a792-141b-42e8-8bd1-884e4408eb8a8
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-378-034354703780330 TABLET, COATED in 1 BOTTLE (43547-378-03) 2016-10-280000-00-00NoNoCurrent
43547-378-5043547037850500 TABLET, COATED in 1 BOTTLE (43547-378-50) 2016-10-280000-00-00NoNoCurrent