FDA.reportPublic FDA data

Eltrombopag

Product NDC
31722-301
11-digit product format
317220301
Labeler code
31722
Product ID
31722-301_315730ec-c40c-af1a-e063-6294a90a010f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eltrombopag olamine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216620
Marketing category
ANDA
Marketing start
2025-05-13
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
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 OLAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4U07F515LG
Rxcui1859498, 2058980

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
31722-301-25Eltrombopag1 in 1 PACKETPOWDER, FOR SUSPENSION11
31722-301-31Eltrombopag30 in 1 CARTONPOWDER, FOR SUSPENSION301
31722-301-32Eltrombopag1 in 1 KITPOWDER, FOR SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-301-25EA - Each31722-301060a79a5-97f5-4f33-b66b-5f88fd0636f312025-06-13
31722-301-32EA - Each31722-301f601a99e-9699-4e6a-8216-9e5f122c876a12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-301ELTROMBOPAG (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20250514_8f6499f0-4774-4f1e-8ab5-145c1fe64401.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058980eltrombopag 12.5 MG Powder for Oral SuspensionPSN8f6499f0-4774-4f1e-8ab5-145c1fe644011
1859498eltrombopag 25 MG Powder for Oral SuspensionPSN8f6499f0-4774-4f1e-8ab5-145c1fe644011
2058980eltrombopag 12.5 MG Powder for Oral SuspensionSCD8f6499f0-4774-4f1e-8ab5-145c1fe644011
1859498eltrombopag 25 MG Powder for Oral SuspensionSCD8f6499f0-4774-4f1e-8ab5-145c1fe644011
1859498eltrombopag (as eltrombopag olamine) 25 MG Powder for Oral SuspensionSY8f6499f0-4774-4f1e-8ab5-145c1fe644011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-301-25317220301251 in 1 PACKETHistorical
31722-301-313172203013130 in 1 CARTONHistorical
31722-301-32317220301321 CARTON in 1 KIT (31722-301-32) / 30 PACKET in 1 CARTON (31722-301-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-301-25) 1 carton2025-05-13NoNoCurrent