voriconazole

Product NDC
0781-5668
11-digit product format
007815668
Labeler code
0781
Product ID
0781-5668_efbbf86a-b798-4963-8786-0d7033ee908b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA200265
Marketing category
ANDA
Marketing start
2011-12-12
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
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
0781-5668-05voriconazole500 in 1 BOTTLETABLET, FILM COATED50023
0781-5668-06voriconazole10 in 1 BLISTER PACKTABLET, FILM COATED1023
0781-5668-10voriconazole1000 in 1 BOTTLETABLET, FILM COATED100023
0781-5668-13voriconazole10 in 1 CARTONTABLET, FILM COATED1023
0781-5668-31voriconazole30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5668-31EA - Each0781-566887d1cb06-0259-43ce-961c-18a4120f3ba212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VORICONAZOLEACTIVE INGREDIENTJFU09I87TRVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
VORICONAZOLEACTIVE MOIETYJFU09I87TRVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11
TRIACETININACTIVE INGREDIENTXHX3C3X673VORICONAZOLE TABLET, FILM COATED [SANDOZ INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5668VORICONAZOLE TABLET, FILM COATED [SANDOZ INC]21Current NDC, Legacy NDC, 5 package rows20250522_e2b3c0b3-02a6-45c3-a8ea-05d210dc9108.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN711e5a1b-8c40-4b18-9f4f-12c8ab351012107
349434voriconazole 200 MG Oral TabletSCD711e5a1b-8c40-4b18-9f4f-12c8ab351012107
349434voriconazole 200 MG Oral TabletPSN35098192-3bcb-9111-e063-6394a90ae8ea100
349434voriconazole 200 MG Oral TabletPSN8217c621-976e-450b-8f48-5dc3119dc53c100
349434voriconazole 200 MG Oral TabletSCD35098192-3bcb-9111-e063-6394a90ae8ea100
349434voriconazole 200 MG Oral TabletSCD8217c621-976e-450b-8f48-5dc3119dc53c100
349434voriconazole 200 MG Oral TabletPSNe2b3c0b3-02a6-45c3-a8ea-05d210dc910823
349435voriconazole 50 MG Oral TabletPSNe2b3c0b3-02a6-45c3-a8ea-05d210dc910823
349434voriconazole 200 MG Oral TabletSCDe2b3c0b3-02a6-45c3-a8ea-05d210dc910823
349435voriconazole 50 MG Oral TabletSCDe2b3c0b3-02a6-45c3-a8ea-05d210dc910823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5668-0500781566805500 TABLET, FILM COATED in 1 BOTTLE (0781-5668-05) 2011-12-120000-00-00NoNoCurrent
0781-5668-060078156680610 in 1 BLISTER PACKHistorical
0781-5668-10007815668101000 TABLET, FILM COATED in 1 BOTTLE (0781-5668-10) 2011-12-120000-00-00NoNoCurrent
0781-5668-130078156681310 BLISTER PACK in 1 CARTON (0781-5668-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5668-06) 10 blister pack2011-12-120000-00-00NoNoCurrent
0781-5668-310078156683130 TABLET, FILM COATED in 1 BOTTLE (0781-5668-31) 2011-12-120000-00-00NoNoCurrent