FDA.reportPublic FDA data

ELTROMBOPAG

Product NDC
31722-843
11-digit product format
317220843
Labeler code
31722
Product ID
31722-843_3de3bb2e-97bf-4a59-e063-6294a90a7744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ELTROMBOPAG
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA206788
Marketing category
ANDA
Marketing start
2025-05-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELTROMBOPAG
Listing expiration
2026-12-31

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
31722-843-14ELTROMBOPAG14 in 1 BOTTLETABLET, FILM COATED142
31722-843-30ELTROMBOPAG30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-843-30EA - Each31722-84309888bfe-c129-463e-8788-d683fe33b2af12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-843ELTROMBOPAG (ELTROMBOPAG) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250514_e913cd11-f5fb-4ebe-81c7-0c5626b52cfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSNe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825421eltrombopag 25 MG Oral TabletPSNe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825427eltrombopag 50 MG Oral TabletPSNe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
884617eltrombopag 75 MG Oral TabletPSNe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
1245001eltrombopag 12.5 MG Oral TabletSCDe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825421eltrombopag 25 MG Oral TabletSCDe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825427eltrombopag 50 MG Oral TabletSCDe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
884617eltrombopag 75 MG Oral TabletSCDe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSYe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSYe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSYe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSYe913cd11-f5fb-4ebe-81c7-0c5626b52cfd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-843-143172208431414 TABLET, FILM COATED in 1 BOTTLE (31722-843-14) 2025-05-20NoNoHistorical
31722-843-303172208433030 TABLET, FILM COATED in 1 BOTTLE (31722-843-30) 2025-05-13NoNoHistorical