HYDREA

Product NDC
0003-0830
11-digit product format
000030830
Labeler code
0003
Product ID
0003-0830_ff7bec97-40a2-46a7-b441-8264c98cc1bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYUREA
Dosage form
CAPSULE
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA016295
Marketing category
NDA
Marketing start
2009-06-01
Marketing end
2025-03-31
Substance
HYDROXYUREA
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite [EPC], Urea [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-0830-50EA - Each0003-08308e0d5268-df71-4424-80d9-f903f5a130d812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0003-0830-5000003083050100 CAPSULE in 1 BOTTLE (0003-0830-50) 100 capsule2009-06-010000-00-00NoNoCurrent