deferasirox

Product NDC
70710-1276
11-digit product format
707101276
Labeler code
70710
Product ID
70710-1276_b011a8f6-9341-4dfb-a7cf-eb30cdae32d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211383
Marketing category
ANDA
Marketing start
2020-06-16
Substance
DEFERASIROX
Active strength
180 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
deferasirox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui1607784, 1607792, 1607796

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
70710-1276-1deferasirox100 in 1 BOTTLETABLET, FILM COATED10012
70710-1276-3deferasirox30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1276-3EA - Each70710-12760d3b05a0-b597-4d3a-8b95-34e62cb1679112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1276DEFERASIROX TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20230725_4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSN4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12
1607792deferasirox 360 MG Oral TabletPSN4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12
1607796deferasirox 90 MG Oral TabletPSN4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12
1607784deferasirox 180 MG Oral TabletSCD4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12
1607792deferasirox 360 MG Oral TabletSCD4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12
1607796deferasirox 90 MG Oral TabletSCD4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1276-170710127601100 TABLET, FILM COATED in 1 BOTTLE (70710-1276-1) 2020-06-160000-00-00NoNoCurrent
70710-1276-37071012760330 TABLET, FILM COATED in 1 BOTTLE (70710-1276-3) 2020-06-160000-00-00NoNoCurrent