Deferiprone

Product NDC
0054-0711
11-digit product format
000540711
Labeler code
0054
Product ID
0054-0711_db72caee-70a3-4561-b855-08b4c9f4a0e0
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
2022-02-08
Substance
DEFERIPRONE
Active strength
1000 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
DEFERIPRONE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BTY8KH53L
Rxcui2180997

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
0054-0711-19Deferiprone50 in 1 BOTTLETABLET, COATED503
0054-0711-23Deferiprone150 in 1 BOTTLETABLET, COATED1503
0054-0711-28Deferiprone300 in 1 BOTTLETABLET, COATED3003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0711-19EA - Each0054-07111c140b73-4cbc-4bbd-aae6-1fd416b6266212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0711DEFERIPRONE TABLET, COATED [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 3 package rows20230912_c4f9e9be-39e7-4940-9cb0-f17772d7e524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletPSNc4f9e9be-39e7-4940-9cb0-f17772d7e5243
2180997deferiprone 1000 MG Oral TabletSCDc4f9e9be-39e7-4940-9cb0-f17772d7e5243
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletSYc4f9e9be-39e7-4940-9cb0-f17772d7e5243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0711-190005407111950 TABLET, COATED in 1 BOTTLE (0054-0711-19) 2022-02-080000-00-00NoNoCurrent
0054-0711-2300054071123150 TABLET, COATED in 1 BOTTLE (0054-0711-23) 2022-02-080000-00-00NoNoCurrent
0054-0711-2800054071128300 TABLET, COATED in 1 BOTTLE (0054-0711-28) 2022-02-080000-00-00NoNoCurrent