Hydroxyurea

Product NDC
55154-3554
11-digit product format
551543554
Labeler code
55154
Product ID
55154-3554_45132fa1-6697-41ae-8ab1-ab40161e215b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyurea
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA075340
Marketing category
ANDA
Marketing start
1999-02-24
Marketing end
0000-00-00
Substance
HYDROXYUREA
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite [EPC], Urea [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3554HYDROXYUREA CAPSULE [CARDINAL HEALTH 107, LLC]3Legacy NDC20241025_45132fa1-6697-41ae-8ab1-ab40161e215b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3554-05515435540010 BLISTER PACK in 1 BAG (55154-3554-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack1999-02-240000-00-00NoNoCurrent