Eltrombopag olamine

Product NDC
70069-837
11-digit product format
700690837
Labeler code
70069
Product ID
70069-837_ec6939e2-4f64-4edd-848c-83e73ffac433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eltrombopag olamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA219638
Marketing category
ANDA
Marketing start
2026-01-14
Substance
ELTROMBOPAG OLAMINE
Active strength
12.5 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 OLAMINE12.5 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
70069-837-01Eltrombopag olamine30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-837-01EA - Each70069-8373890d79b-f8f0-4446-a324-216b2f96980012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN604f663c-4933-402a-8105-5921713cf3c87
825421eltrombopag 25 MG Oral TabletPSN604f663c-4933-402a-8105-5921713cf3c87
825427eltrombopag 50 MG Oral TabletPSN604f663c-4933-402a-8105-5921713cf3c87
884617eltrombopag 75 MG Oral TabletPSN604f663c-4933-402a-8105-5921713cf3c87
1245001eltrombopag 12.5 MG Oral TabletSCD604f663c-4933-402a-8105-5921713cf3c87
825421eltrombopag 25 MG Oral TabletSCD604f663c-4933-402a-8105-5921713cf3c87
825427eltrombopag 50 MG Oral TabletSCD604f663c-4933-402a-8105-5921713cf3c87
884617eltrombopag 75 MG Oral TabletSCD604f663c-4933-402a-8105-5921713cf3c87
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY604f663c-4933-402a-8105-5921713cf3c87
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY604f663c-4933-402a-8105-5921713cf3c87
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY604f663c-4933-402a-8105-5921713cf3c87
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY604f663c-4933-402a-8105-5921713cf3c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70069-837-017006908370130 TABLET, FILM COATED in 1 BOTTLE (70069-837-01) 2026-01-14NoNoCurrent