voriconazole

Product NDC
70436-029
11-digit product format
704360029
Labeler code
70436
Product ID
70436-029_5134712f-f9ea-09cf-e063-6294a90addf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals
Application
ANDA211661
Marketing category
ANDA
Marketing start
2019-01-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
voriconazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFU09I87TR
Rxcui351209

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
70436-029-80voriconazole1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-029-80EA - Each70436-029a7aa0180-b2b9-4122-8dca-2c5863a3892612019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-029VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20240830_7f2e0784-8e48-f565-e053-2991aa0a0746.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351209voriconazole 200 MG InjectionPSN7f2e0784-8e48-f565-e053-2991aa0a074610
351209voriconazole 200 MG InjectionSCD7f2e0784-8e48-f565-e053-2991aa0a074610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-029-80704360029801 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70436-029-80) 2019-01-280000-00-00NoNoCurrent