deferasirox

Product NDC
69097-391
11-digit product format
690970391
Labeler code
69097
Product ID
69097-391_dfe125b8-f47a-4e92-96f2-08eff47d838f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA211852
Marketing category
ANDA
Marketing start
2020-02-13
Marketing end
0000-00-00
Substance
DEFERASIROX
Active strength
90 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-391-02EA - Each69097-391a73e1282-2c66-4ef4-ba3e-cf325eb4ef6612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-391DEFERASIROX TABLET, COATED [CIPLA USA INC.]5Legacy NDC20211103_31df70cb-f6a0-4cba-a02c-dc9fa6bd63bd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-391-026909703910230 TABLET, COATED in 1 BOTTLE (69097-391-02) 2020-02-130000-00-00NoNoCurrent
69097-391-20690970391205 BLISTER PACK in 1 CARTON (69097-391-20) > 10 TABLET, COATED in 1 BLISTER PACK (69097-391-19) 5 blister pack2020-02-130000-00-00NoNoCurrent