FDA.reportPublic FDA data

ELTROMBOPAG

Product NDC
72865-301
11-digit product format
728650301
Labeler code
72865
Product ID
72865-301_3bc65bc5-9a03-0ece-e063-6394a90a0a7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ELTROMBOPAG
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA206788
Marketing category
ANDA
Marketing start
2025-08-07
Substance
ELTROMBOPAG OLAMINE
Active strength
50 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELTROMBOPAG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG OLAMINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4U07F515LG
Rxcui825421, 825427, 884617, 1245001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
349df11e-99eb-4fff-8cd5-538adda21b14Product name320251110
4db6dd95-5e83-4752-b5e1-62f824423c50Product name120241217
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-301-14ELTROMBOPAG14 in 1 BOTTLETABLET, FILM COATED141
72865-301-30ELTROMBOPAG30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-301-30EA - Each72865-301976ada00-2ada-475a-ae3a-ac78be50da1612025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825421eltrombopag 25 MG Oral TabletPSN9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825427eltrombopag 50 MG Oral TabletPSN9af1e314-91ca-4ebc-ac12-f9fddc6d79021
884617eltrombopag 75 MG Oral TabletPSN9af1e314-91ca-4ebc-ac12-f9fddc6d79021
1245001eltrombopag 12.5 MG Oral TabletSCD9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825421eltrombopag 25 MG Oral TabletSCD9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825427eltrombopag 50 MG Oral TabletSCD9af1e314-91ca-4ebc-ac12-f9fddc6d79021
884617eltrombopag 75 MG Oral TabletSCD9af1e314-91ca-4ebc-ac12-f9fddc6d79021
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY9af1e314-91ca-4ebc-ac12-f9fddc6d79021
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY9af1e314-91ca-4ebc-ac12-f9fddc6d79021
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY9af1e314-91ca-4ebc-ac12-f9fddc6d79021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72865-301-147286503011414 TABLET, FILM COATED in 1 BOTTLE (72865-301-14) 2025-08-07NoNoHistorical
72865-301-307286503013030 TABLET, FILM COATED in 1 BOTTLE (72865-301-30) 2025-08-07NoNoHistorical