FDA.reportPublic FDA data

Deferiprone

Product NDC
0054-0576
11-digit product format
000540576
Labeler code
0054
Product ID
0054-0576_85bc2162-59ea-409a-94c2-0edef74922f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deferiprone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213239
Marketing category
ANDA
Marketing start
2021-06-03
Substance
DEFERIPRONE
Active strength
500 mg/1
Pharmacologic classes
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
Deferiprone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERIPRONE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BTY8KH53L
Rxcui389242

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a80eb9dc-2190-fd13-788a-836e044e09a9Product name420210927
ee8776d9-85a0-4e53-8dc8-f4ae23ba4929Product name120201008
6708d2db-3abd-41fb-b674-120f69c5a63aProduct name120180621
222e639a-0425-48b8-8bdb-5ab1d9731285Product name120151028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0576-25Deferiprone100 in 1 BOTTLETABLET, COATED1008
0054-0576-28Deferiprone300 in 1 BOTTLETABLET, COATED3008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0576-25EA - Each0054-05765de2aa53-82c5-4bc4-b54a-ae2acd5efefe12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0576DEFERIPRONE TABLET, COATED [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20240215_d7ea0a84-c328-4636-8cd6-ad75f2074b22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
389242deferiprone 500 MG Three-Times-A-Day Oral TabletPSNd7ea0a84-c328-4636-8cd6-ad75f2074b228
389242deferiprone 500 MG Oral TabletSCDd7ea0a84-c328-4636-8cd6-ad75f2074b228
389242deferiprone 500 MG Three-Times-A-Day Oral TabletSYd7ea0a84-c328-4636-8cd6-ad75f2074b228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0576-2500054057625100 TABLET, COATED in 1 BOTTLE (0054-0576-25) 2021-06-030000-00-00NoNoCurrent
0054-0576-2800054057628300 TABLET, COATED in 1 BOTTLE (0054-0576-28) 2021-06-030000-00-00NoNoCurrent