Home NDC 24535-0831 Hydroxyurea
Product NDC 24535-0831
11-digit product format 245350831
Labeler code 24535
Product ID 24535-0831_8ff7b994-411f-481b-9923-311a1e3505c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyurea
Dosage form CAPSULE
Route ORAL
Labeler Arab Pharmaceutical Manufacturing Co. PSC Ltd
Application ANDA204998
Marketing category ANDA
Marketing start 2017-08-20
Marketing end 0000-00-00
Substance HYDROXYUREA
Active strength 500 mg/1
Pharmacologic classes Antimetabolite [EPC],Urea [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 24535-0831-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 24535-0831-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 24535-0831-1 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
FDA-Initiated Inactive NDC Indexing#