Eltrombopag Olamine

Product NDC
60219-1414
11-digit product format
602191414
Labeler code
60219
Product ID
60219-1414_992e50d5-b6c2-4213-9c7c-ef25c84d0708
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
75 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 OLAMINE75 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
60219-1414-3Eltrombopag Olamine30 in 1 BOTTLETABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1414-3EA - Each60219-1414a2e2a898-e3f8-4133-bb73-785d680b46c612026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN05acf38e-7870-4809-a045-fc38e66b111013
825421eltrombopag 25 MG Oral TabletPSN05acf38e-7870-4809-a045-fc38e66b111013
825427eltrombopag 50 MG Oral TabletPSN05acf38e-7870-4809-a045-fc38e66b111013
884617eltrombopag 75 MG Oral TabletPSN05acf38e-7870-4809-a045-fc38e66b111013
1245001eltrombopag 12.5 MG Oral TabletSCD05acf38e-7870-4809-a045-fc38e66b111013
825421eltrombopag 25 MG Oral TabletSCD05acf38e-7870-4809-a045-fc38e66b111013
825427eltrombopag 50 MG Oral TabletSCD05acf38e-7870-4809-a045-fc38e66b111013
884617eltrombopag 75 MG Oral TabletSCD05acf38e-7870-4809-a045-fc38e66b111013
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY05acf38e-7870-4809-a045-fc38e66b111013
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY05acf38e-7870-4809-a045-fc38e66b111013
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY05acf38e-7870-4809-a045-fc38e66b111013
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY05acf38e-7870-4809-a045-fc38e66b111013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-1414-36021914140330 TABLET, FILM COATED in 1 BOTTLE (60219-1414-3) 2026-01-15NoNoHistorical