Home NDC 0078-0697 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207027-001 PROMACTA KIT ELTROMBOPAG OLAMINE EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 N207027-002 PROMACTA KIT ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 N207027-001 7547719*PED 2026-01-13 Pediatric extension N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 N207027-002 7547719*PED 2026-01-13 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N207027-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-001 7547719*PED 2026-01-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N207027-002 7547719*PED 2026-01-13 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROMACTA ELTROMBOPAG OLAMINE Novartis Pharmaceuticals Corporation 7714a0ed-34bb-46e6-a0a5-b363908b22c2 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207027 application number: NDA207027 ndc (product): 0078-0697
Additional Listing Data#
Finished product Yes
Brand name base PROMACTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELTROMBOPAG OLAMINE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4U07F515LG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 825421 Internal RxNorm lookup 825425 Internal RxNorm lookup 825427 Internal RxNorm lookup 825429 Internal RxNorm lookup 884617 Internal RxNorm lookup 884619 Internal RxNorm lookup 1245001 Internal RxNorm lookup 1245003 Internal RxNorm lookup 1859498 Internal RxNorm lookup 1859501 Internal RxNorm lookup 2058980 Internal RxNorm lookup 2058981 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0697-19 PROMACTA 1 in 1 PACKET POWDER, FOR SUSPENSION 1 31 0078-0697-23 PROMACTA 30 in 1 CARTON POWDER, FOR SUSPENSION 30 31 0078-0697-61 PROMACTA 1 in 1 KIT POWDER, FOR SUSPENSION 1 31
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0697 PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 28 Current NDC, Legacy NDC, 3 package rows 20250105_7714a0ed-34bb-46e6-a0a5-b363908b22c2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0697-19 00078069719 1 in 1 PACKET Historical 0078-0697-23 00078069723 30 in 1 CARTON Historical 0078-0697-61 00078069761 1 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 carton 2020-03-27 0000-00-00 No No Current