FDA.reportPublic FDA data

Deferasirox Oral Granules

Product NDC
42806-373
11-digit product format
428060373
Labeler code
42806
Product ID
42806-373_2b205859-07ad-1703-e063-6394a90ac140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferasirox
Dosage form
GRANULE
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA214559
Marketing category
ANDA
Marketing start
2022-10-06
Substance
DEFERASIROX
Active strength
360 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 Oral Granules
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERASIROX360 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV8G4MOF2V9
Rxcui1923822, 1923826, 1923828

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
42806-373-30Deferasirox Oral Granules30 in 1 CARTONGRANULE304
42806-373-30Deferasirox Oral Granules1 in 1 PACKETGRANULE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-373-30EA - Each42806-37379a00018-a508-45d8-b6f1-91dbc5c2620912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-373DEFERASIROX ORAL GRANULES (DEFERASIROX) GRANULE [EPIC PHARMA, LLC]4Current NDC, 2 package rows20250109_7eda83c3-a282-47f6-9f06-d2f9612f5c5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923828deferasirox 180 MG Oral GranulesPSN7eda83c3-a282-47f6-9f06-d2f9612f5c5b4
1923826deferasirox 360 MG Oral GranulesPSN7eda83c3-a282-47f6-9f06-d2f9612f5c5b4
1923822deferasirox 90 MG Oral GranulesPSN7eda83c3-a282-47f6-9f06-d2f9612f5c5b4
1923828deferasirox 180 MG Oral GranulesSCD7eda83c3-a282-47f6-9f06-d2f9612f5c5b4
1923826deferasirox 360 MG Oral GranulesSCD7eda83c3-a282-47f6-9f06-d2f9612f5c5b4
1923822deferasirox 90 MG Oral GranulesSCD7eda83c3-a282-47f6-9f06-d2f9612f5c5b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-373-304280603733030 PACKET in 1 CARTON (42806-373-30) / 1 GRANULE in 1 PACKET30 packet2022-10-06NoNoCurrent