Deferasirox

Product NDC
69238-1487
11-digit product format
692381487
Labeler code
69238
Product ID
69238-1487_0b0b3d91-33d4-46b8-8bdc-fb9b5a9e99c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferasirox
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210727
Marketing category
ANDA
Marketing start
2020-06-15
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
69238-1487-3Deferasirox30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1487-3EA - Each69238-1487feabcc09-3dc3-460c-9e6f-a3dab4585bd912020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1487DEFERASIROX TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 1 package rows20231230_a7ae9c31-e14f-4cf9-9ab3-850519f1a87c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSNa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13
1607792deferasirox 360 MG Oral TabletPSNa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13
1607796deferasirox 90 MG Oral TabletPSNa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13
1607784deferasirox 180 MG Oral TabletSCDa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13
1607792deferasirox 360 MG Oral TabletSCDa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13
1607796deferasirox 90 MG Oral TabletSCDa7ae9c31-e14f-4cf9-9ab3-850519f1a87c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1487-36923814870330 TABLET, FILM COATED in 1 BOTTLE (69238-1487-3) 2020-06-150000-00-00NoNoCurrent