Deferasirox

Product NDC
45963-454
11-digit product format
459630454
Labeler code
45963
Product ID
45963-454_ff13b6ff-e95c-47ed-b21b-6cac71aff318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA203560
Marketing category
ANDA
Marketing start
2019-03-22
Marketing end
0000-00-00
Substance
DEFERASIROX
Active strength
125 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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e1ec29c-8ce7-9963-3c87-cf7d9cd3b139Product name520250624
0feb0248-301d-406d-9b41-7d80ddbec8a8Product name420201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-454-30Deferasirox30 in 1 BOTTLETABLET, FOR SUSPENSION3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-454-30EA - Each45963-4543d3b6d3b-9d10-42ad-853d-6b9d954da90212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-454DEFERASIROX TABLET, FOR SUSPENSION [ACTAVIS PHARMA, INC.]28Legacy NDC, 1 package rows20241103_ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597768deferasirox 125 MG Tablet for Oral SuspensionPSNad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529
597770deferasirox 250 MG Tablet for Oral SuspensionPSNad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529
597772deferasirox 500 MG Tablet for Oral SuspensionPSNad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529
597768deferasirox 125 MG Tablet for Oral SuspensionSCDad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529
597770deferasirox 250 MG Tablet for Oral SuspensionSCDad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529
597772deferasirox 500 MG Tablet for Oral SuspensionSCDad73cb1f-41d6-4cde-9abc-fc2cb7e04c9529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-454-304596304543030 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-454-30) 2019-03-220000-00-00NoNoCurrent