FDA.reportPublic FDA data

FERRIPROX

Product NDC
10122-103
11-digit product format
101220103
Labeler code
10122
Product ID
10122-103_f6d7984f-011e-4a3f-bcf5-6a5b2b6ef2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEFERIPRONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chiesi USA, Inc.
Application
NDA021825
Marketing category
NDA
Marketing start
2019-08-01
Substance
DEFERIPRONE
Active strength
1000 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FERRIPROX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERIPRONE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BTY8KH53L
Rxcui389242, 1190357, 2180997, 2180999, 2685014, 2685015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a80eb9dc-2190-fd13-788a-836e044e09a9Product name420210927
ee8776d9-85a0-4e53-8dc8-f4ae23ba4929Product name120201008
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
6708d2db-3abd-41fb-b674-120f69c5a63aProduct name120180621
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
222e639a-0425-48b8-8bdb-5ab1d9731285Product name120151028
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-103-05FERRIPROX50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-103-05EA - Each10122-103abfcfe7e-1e2d-40d2-b8ac-5bd6d96dd27512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-103FERRIPROX (DEFERIPRONE) TABLET FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [CHIESI USA, INC.]13Current NDC, Legacy NDC, 1 package rows20250417_946718ff-df43-1baa-74d1-e5bcfbe8ad86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685014deferiprone 1000 MG Twice-Daily Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
389242deferiprone 500 MG Three-Times-A-Day Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2180999Ferriprox 1000 MG Three-Times-A-Day Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685015Ferriprox 1000 MG Twice-Daily Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
1190357Ferriprox 500 MG Three-Times-A-Day Oral TabletPSN946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2180999deferiprone 1000 MG Oral Tablet [Ferriprox]SBD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
1190357deferiprone 500 MG Oral Tablet [Ferriprox]SBD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685015Twice-Daily deferiprone 1000 MG Oral Tablet [Ferriprox]SBD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2180997deferiprone 1000 MG Oral TabletSCD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
389242deferiprone 500 MG Oral TabletSCD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685014Twice-Daily deferiprone 1000 MG Oral TabletSCD946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685014deferiprone 1000 MG Twice-Daily Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
389242deferiprone 500 MG Three-Times-A-Day Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2180999Ferriprox 1000 MG Three-Times-A-Day Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685015Ferriprox 1000 MG Twice-Daily Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
1190357Ferriprox 500 MG Three-Times-A-Day Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615
2685015Twice-Daily Ferriprox 1000 MG Oral TabletSY946718ff-df43-1baa-74d1-e5bcfbe8ad8615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10122-103-051012201030550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-103-05) 2019-08-010000-00-00NoNoCurrent