deferasirox

Product NDC
69238-1704
11-digit product format
692381704
Labeler code
69238
Product ID
69238-1704_30a9b4e3-6d26-43b3-87ba-855df34c9e8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
GRANULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214194
Marketing category
ANDA
Marketing start
2021-02-09
Marketing end
0000-00-00
Substance
DEFERASIROX
Active strength
360 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1704-1EA - Each69238-17040210cedc-15fa-4185-925c-46132f9149da12021-03-02
69238-1704-3EA - Each69238-1704db82a174-4eaa-447b-a0d9-3ef53a96f20512021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1704DEFERASIROX GRANULE [AMNEAL PHARMACEUTICALS NY LLC]14Legacy NDC20231230_19f4b412-3d35-4e31-80b6-f13d26c300c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1704-1692381704011 GRANULE in 1 PACKET (69238-1704-1) 1 granule2021-02-090000-00-00NoNoCurrent
69238-1704-36923817040330 GRANULE in 1 CARTON (69238-1704-3) 30 granule2021-02-090000-00-00NoNoCurrent