Hydroxyurea

Product NDC
10135-702
11-digit product format
101350702
Labeler code
10135
Product ID
10135-702_d8383e21-6b7c-18c3-e053-2995a90a8401
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyurea
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA213438
Marketing category
ANDA
Marketing start
2022-01-28
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 Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-702-01Hydroxyurea100 in 1 BOTTLE, PLASTICCAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-702-01EA - Each10135-702901aee17-31fb-4217-9f02-1d285944407912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-702HYDROXYUREA CAPSULE [MARLEX PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20231109_d8383e21-6b7b-18c3-e053-2995a90a8401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197797hydroxyurea 500 MG Oral CapsulePSNd8383e21-6b7b-18c3-e053-2995a90a84012
197797hydroxyurea 500 MG Oral CapsuleSCDd8383e21-6b7b-18c3-e053-2995a90a84012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-702-0110135070201100 CAPSULE in 1 BOTTLE, PLASTIC (10135-702-01) 100 capsule2022-01-280000-00-00NoNoCurrent