FDA.reportPublic FDA data

DEFERASIROX

Product NDC
62332-411
11-digit product format
623320411
Labeler code
62332
Product ID
62332-411_6d1323aa-ee46-43aa-bcf0-d83a36788a1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEFERASIROX
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211824
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
62332-411-30DEFERASIROX30 in 1 BOTTLETABLET, FILM COATED3017
62332-411-91DEFERASIROX1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-411-30EA - Each62332-4110a40dc8f-c06d-47aa-935a-4f5bd775d8af12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-411DEFERASIROX TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20230527_f1f952c8-89f5-4a2f-bd6b-9b384366d971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607784deferasirox 180 MG Oral TabletPSNf1f952c8-89f5-4a2f-bd6b-9b384366d97117
1607792deferasirox 360 MG Oral TabletPSNf1f952c8-89f5-4a2f-bd6b-9b384366d97117
1607796deferasirox 90 MG Oral TabletPSNf1f952c8-89f5-4a2f-bd6b-9b384366d97117
1607784deferasirox 180 MG Oral TabletSCDf1f952c8-89f5-4a2f-bd6b-9b384366d97117
1607792deferasirox 360 MG Oral TabletSCDf1f952c8-89f5-4a2f-bd6b-9b384366d97117
1607796deferasirox 90 MG Oral TabletSCDf1f952c8-89f5-4a2f-bd6b-9b384366d97117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-411-306233204113030 TABLET, FILM COATED in 1 BOTTLE (62332-411-30) 2020-06-150000-00-00NoNoCurrent
62332-411-91623320411911000 TABLET, FILM COATED in 1 BOTTLE (62332-411-91) 2020-06-150000-00-00NoNoCurrent