FDA.reportPublic FDA data

Eltrombopag Olamine

Product NDC
69238-1415
11-digit product format
692381415
Labeler code
69238
Product ID
69238-1415_8dba449a-e27a-4f76-a831-6774aa89c217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eltrombopag
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212884
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1415-3Eltrombopag Olamine30 in 1 BOTTLETABLET, FILM COATED304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSNc97337c3-d758-40a3-a1ef-fd122f15e8214
825421eltrombopag 25 MG Oral TabletPSNc97337c3-d758-40a3-a1ef-fd122f15e8214
825427eltrombopag 50 MG Oral TabletPSNc97337c3-d758-40a3-a1ef-fd122f15e8214
884617eltrombopag 75 MG Oral TabletPSNc97337c3-d758-40a3-a1ef-fd122f15e8214
1245001eltrombopag 12.5 MG Oral TabletSCDc97337c3-d758-40a3-a1ef-fd122f15e8214
825421eltrombopag 25 MG Oral TabletSCDc97337c3-d758-40a3-a1ef-fd122f15e8214
825427eltrombopag 50 MG Oral TabletSCDc97337c3-d758-40a3-a1ef-fd122f15e8214
884617eltrombopag 75 MG Oral TabletSCDc97337c3-d758-40a3-a1ef-fd122f15e8214
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSYc97337c3-d758-40a3-a1ef-fd122f15e8214
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSYc97337c3-d758-40a3-a1ef-fd122f15e8214
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSYc97337c3-d758-40a3-a1ef-fd122f15e8214
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSYc97337c3-d758-40a3-a1ef-fd122f15e8214
1245001eltrombopag 12.5 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag 25 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag 50 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag 75 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
1245001eltrombopag 12.5 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag 25 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag 50 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag 75 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-1415-36923814150330 TABLET, FILM COATED in 1 BOTTLE (69238-1415-3) 2026-01-15NoNoHistorical