FDA.reportPublic FDA data

ELTROMBOPAG

Product NDC
70710-1397
11-digit product format
707101397
Labeler code
70710
Product ID
70710-1397_8f8b3109-d174-4138-b14f-f956a4578ca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eltrombopag
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA216281
Marketing category
ANDA
Marketing start
2026-01-14
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
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
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1397-3ELTROMBOPAG30 in 1 BOTTLETABLET302
70710-1397-7ELTROMBOPAG14 in 1 BOTTLETABLET142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825421eltrombopag 25 MG Oral TabletPSN1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825427eltrombopag 50 MG Oral TabletPSN1cfdd1fa-d687-41f9-a160-9491f0beac1e2
884617eltrombopag 75 MG Oral TabletPSN1cfdd1fa-d687-41f9-a160-9491f0beac1e2
1245001eltrombopag 12.5 MG Oral TabletSCD1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825421eltrombopag 25 MG Oral TabletSCD1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825427eltrombopag 50 MG Oral TabletSCD1cfdd1fa-d687-41f9-a160-9491f0beac1e2
884617eltrombopag 75 MG Oral TabletSCD1cfdd1fa-d687-41f9-a160-9491f0beac1e2
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY1cfdd1fa-d687-41f9-a160-9491f0beac1e2
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY1cfdd1fa-d687-41f9-a160-9491f0beac1e2
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY1cfdd1fa-d687-41f9-a160-9491f0beac1e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1397-37071013970330 TABLET in 1 BOTTLE (70710-1397-3) 30 tablet2026-01-14NoNoCurrent
70710-1397-77071013970714 TABLET in 1 BOTTLE (70710-1397-7) 14 tablet2026-01-14NoNoCurrent