FDA.reportPublic FDA data

PROMACTA

Product NDC
0078-0684
11-digit product format
000780684
Labeler code
0078
Product ID
0078-0684_b8a1cc48-9aaf-486a-9305-090acccb5c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eltrombopag olamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022291
Marketing category
NDA
Marketing start
2016-08-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG OLAMINE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4U07F515LG
Rxcui825421, 825425, 825427, 825429, 884617, 884619, 1245001, 1245003, 1859498, 1859501, 2058980, 2058981

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0684-152023-08-01C16284748780-10191ceaa-6a00-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use PROMACTA safely and effectively. See full prescribing information for PROMACTA. PROMACTA ® (eltrombopag) tablets, for oral use PROMACTA ® (eltrombopag) for oral suspension Initial U.S. Approval: 2008
0078-0684-152023-07-28C16284748780-10191ceaa-6a00-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use PROMACTA safely and effectively. See full prescribing information for PROMACTA. PROMACTA ® (eltrombopag) tablets, for oral use PROMACTA ® (eltrombopag) for oral suspension Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0684-15PROMACTA30 in 1 BOTTLETABLET, FILM COATED3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0684-15EA - Each0078-06842e7bb28d-0ecc-42d3-9795-98b38beea59e12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0684PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]28Current NDC, Legacy NDC, 1 package rows20250105_7714a0ed-34bb-46e6-a0a5-b363908b22c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
2058980eltrombopag 12.5 MG Powder for Oral SuspensionPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
825421eltrombopag 25 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859498eltrombopag 25 MG Powder for Oral SuspensionPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
825427eltrombopag 50 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
884617eltrombopag 75 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245003Promacta 12.5 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
2058981Promacta 12.5 MG Powder for Oral SuspensionPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
825425Promacta 25 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859501Promacta 25 MG Powder for Oral SuspensionPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
825429Promacta 50 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
884619Promacta 75 MG Oral TabletPSN7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245003eltrombopag 12.5 MG Oral Tablet [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
2058981eltrombopag 12.5 MG Powder for Oral Suspension [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
825425eltrombopag 25 MG Oral Tablet [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859501eltrombopag 25 MG Powder for Oral Suspension [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
825429eltrombopag 50 MG Oral Tablet [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
884619eltrombopag 75 MG Oral Tablet [Promacta]SBD7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245001eltrombopag 12.5 MG Oral TabletSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
2058980eltrombopag 12.5 MG Powder for Oral SuspensionSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
825421eltrombopag 25 MG Oral TabletSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859498eltrombopag 25 MG Powder for Oral SuspensionSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
825427eltrombopag 50 MG Oral TabletSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
884617eltrombopag 75 MG Oral TabletSCD7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859498eltrombopag (as eltrombopag olamine) 25 MG Powder for Oral SuspensionSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245003Promacta (as eltrombopag olamine) 12.5 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
2058981Promacta (as eltrombopag olamine) 12.5 MG Powder for Oral SuspensionSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825425Promacta (as eltrombopag olamine) 25 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825429Promacta (as eltrombopag olamine) 50 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
884619Promacta (as eltrombopag olamine) 75 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
1245003Promacta 12.5 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825425Promacta 25 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859501Promacta 25 MG Powder for Oral SuspensionSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
825429Promacta 50 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
884619Promacta 75 MG Oral TabletSY7714a0ed-34bb-46e6-a0a5-b363908b22c231
1859501Promacta eltrombopag 25 MG (as eltrombopag olamine) Powder for Oral SuspensionSY7714a0ed-34bb-46e6-a0a5-b363908b22c231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0684-150007806841530 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15) 2016-08-220000-00-00NoNoCurrent