FDA.reportPublic FDA data

HYDROXYUREA

Product NDC
42291-321
11-digit product format
422910321
Labeler code
42291
Product ID
42291-321_4133de1c-b333-3b84-e063-6294a90a2432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyurea
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA075143
Marketing category
ANDA
Marketing start
2013-07-23
Substance
HYDROXYUREA
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite [EPC], Urea [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROXYUREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYUREA500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX6Q56QN5QC
Rxcui197797

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9be3ebe6-89e5-4e2f-8781-a389e7eb49e7Product name120250129
f76fb619-09b6-d149-3287-3661f7bc38cdProduct name320250124
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
62a0eedf-9497-47af-bccf-d51b8b15b067Product name120180307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-321-01HYDROXYUREA100 in 1 BOTTLECAPSULE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-321-01EA - Each42291-321c047b8e5-0e05-489f-8b70-96a2cf75e3b312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYUREAACTIVE INGREDIENTX6Q56QN5QCHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
HYDROXYUREAACTIVE MOIETYX6Q56QN5QCHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYUREA (HYDROXYUREA) CAPSULE [AVKARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-321HYDROXYUREA CAPSULE [AVKARE]8Current NDC, Legacy NDC, 1 package rows20220114_862583ff-6d5c-3f7d-e3bd-352fb0400928.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197797hydroxyurea 500 MG Oral CapsulePSN862583ff-6d5c-3f7d-e3bd-352fb040092810
197797hydroxyurea 500 MG Oral CapsuleSCD862583ff-6d5c-3f7d-e3bd-352fb040092810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-321-0142291032101100 CAPSULE in 1 BOTTLE (42291-321-01) 100 capsule2013-07-230000-00-00NoNoCurrent