FDA.reportPublic FDA data

ZYFLO

Product NDC
10122-901
11-digit product format
101220901
Labeler code
10122
Product ID
10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zileuton
Dosage form
TABLET
Route
ORAL
Labeler
Chiesi USA, Inc.
Application
NDA020471
Marketing category
NDA
Marketing start
1996-12-06
Marketing end
2027-11-30
Substance
ZILEUTON
Active strength
600 mg/1
Pharmacologic classes
5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYFLO

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZILEUTON600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1L22WVE2S
Rxcui199904, 211777

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ab1cd6a-2e03-4fd2-842b-497a1f1ff461Product name420231219
4fad46b7-5f43-5163-8976-8a0f23153295Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-901-12ZYFLO120 in 1 BOTTLETABLET12033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-901-12EA - Each10122-9015e5bd7ef-9cdb-4c12-8ee7-ce540f3796b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZILEUTONACTIVE INGREDIENTV1L22WVE2SZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
ZILEUTONACTIVE MOIETYV1L22WVE2SZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
TALCINACTIVE INGREDIENT7SEV7J4R1UZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-901ZYFLO (ZILEUTON) TABLET [CHIESI USA, INC.]30Current NDC, Legacy NDC, 1 package rows20220114_aee65202-fddb-497f-9f11-17cc727cb157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199904zileuton 600 MG Oral TabletPSNaee65202-fddb-497f-9f11-17cc727cb15733
211777Zyflo 600 MG Oral TabletPSNaee65202-fddb-497f-9f11-17cc727cb15733
211777zileuton 600 MG Oral Tablet [Zyflo]SBDaee65202-fddb-497f-9f11-17cc727cb15733
199904zileuton 600 MG Oral TabletSCDaee65202-fddb-497f-9f11-17cc727cb15733
211777Zyflo 600 MG Oral TabletSYaee65202-fddb-497f-9f11-17cc727cb15733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10122-901-1210122090112120 TABLET in 1 BOTTLE (10122-901-12) 120 tablet1996-12-062027-11-30NoNoCurrent