FDA.reportPublic FDA data

voriconazole

Product NDC
70436-230
11-digit product format
704360230
Labeler code
70436
Product ID
70436-230_3e5a72cf-40b2-0e01-e063-6294a90a698d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA216805
Marketing category
ANDA
Marketing start
2024-03-01
Substance
VORICONAZOLE
Active strength
40 mg/mL
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
VORICONAZOLE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui465355

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-230-39voriconazole1 in 1 CARTONPOWDER, FOR SUSPENSION14
70436-230-39voriconazole75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION754

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-230-39ML - Milliliter70436-2304a2265ef-32f6-474a-bc18-b765a2b2633712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-230VORICONAZOLE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20250403_2b262849-9a29-44a2-9b9d-2378f771379c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
465355voriconazole 40 MG in 1 mL Oral SuspensionPSN2b262849-9a29-44a2-9b9d-2378f771379c4
465355voriconazole 40 MG/ML Oral SuspensionSCD2b262849-9a29-44a2-9b9d-2378f771379c4
465355voriconazole 200 MG/5 ML Oral SuspensionSY2b262849-9a29-44a2-9b9d-2378f771379c4
465355voriconazole 40 MG per 1 ML Oral SuspensionSY2b262849-9a29-44a2-9b9d-2378f771379c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-230-39704360230391 BOTTLE in 1 CARTON (70436-230-39) / 75 mL in 1 BOTTLE1 bottle2024-03-01NoNoHistorical