FDA.reportPublic FDA data

PROMACTA

Product NDC
0078-0697
11-digit product format
000780697
Labeler code
0078
Product ID
0078-0697_b8a1cc48-9aaf-486a-9305-090acccb5c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eltrombopag olamine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA207027
Marketing category
NDA
Marketing start
2018-09-27
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
PROMACTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG OLAMINE25 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
0078-0697-612023-08-01C16284748780-10191ceaa-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
0078-0697-612023-07-28C16284748780-10191ceaa-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
0078-0697-19PROMACTA1 in 1 PACKETPOWDER, FOR SUSPENSION131
0078-0697-23PROMACTA30 in 1 CARTONPOWDER, FOR SUSPENSION3031
0078-0697-61PROMACTA1 in 1 KITPOWDER, FOR SUSPENSION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0697-19EA - Each0078-0697f2f3864a-0b2d-45e8-8b14-64884c41eb7912020-05-08
0078-0697-23EA - Each0078-0697c7824f3f-8153-4f45-b4e5-b758c4d3add512021-02-05
0078-0697-61EA - Each0078-0697a69cf3b6-93e7-4b9f-9380-edc63ab3b36112020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0697PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]28Current NDC, Legacy NDC, 3 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0697-19000780697191 in 1 PACKETHistorical
0078-0697-230007806972330 in 1 CARTONHistorical
0078-0697-61000780697611 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) 1 carton2020-03-270000-00-00NoNoCurrent