FDA.reportPublic FDA data

eltrombopag

Product NDC
72205-157
11-digit product format
722050157
Labeler code
72205
Product ID
72205-157_5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eltrombopag olamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA220250
Marketing category
ANDA
Marketing start
2026-01-14
Substance
ELTROMBOPAG OLAMINE
Active strength
25 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 OLAMINE25 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-157-30eltrombopag30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-157-30EA - Each72205-157e20849c3-476e-4e3b-94ea-7fdde377b13012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825421eltrombopag 25 MG Oral TabletPSN5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825427eltrombopag 50 MG Oral TabletPSN5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
884617eltrombopag 75 MG Oral TabletPSN5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
1245001eltrombopag 12.5 MG Oral TabletSCD5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825421eltrombopag 25 MG Oral TabletSCD5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825427eltrombopag 50 MG Oral TabletSCD5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
884617eltrombopag 75 MG Oral TabletSCD5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-157-307220501573030 TABLET, FILM COATED in 1 BOTTLE (72205-157-30) 2026-01-14NoNoCurrent