Home NDC 0007-4640 PROMACTA
Product NDC 0007-4640
11-digit product format 000074640
Labeler code 0007
Product ID 0007-4640_c7c46a73-1f77-45f6-ab60-1aa8f9e87463
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eltrombopag olamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA022291
Marketing category NDA
Marketing start 2008-11-24
Marketing end 2019-04-30
Substance ELTROMBOPAG OLAMINE
Active strength 25 mg/1
Pharmacologic classes Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022291-001 PROMACTA ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 N022291-002 PROMACTA ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 N022291-003 PROMACTA ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 N022291-004 PROMACTA ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 N022291-005 PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 79 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-001 7547719*PED 2026-01-13 Pediatric extension N022291-001 8052993 2027-08-01 U-1306 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-1575 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-2451 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-930 Drug product 2011-12-07 N022291-001 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-001 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-001 8052993*PED 2028-02-01 Pediatric extension N022291-001 8052994*PED 2028-02-01 Pediatric extension N022291-001 8062665*PED 2028-02-01 Pediatric extension N022291-001 8071129*PED 2028-02-01 Pediatric extension N022291-001 8828430*PED 2028-02-01 Pediatric extension N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-002 7547719*PED 2026-01-13 Pediatric extension N022291-002 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8052994 2027-08-01 U-1306 Drug product 2011-12-07 N022291-002 8052994 2027-08-01 U-2451 Drug product 2011-12-07 N022291-002 8052994 2027-08-01 U-930 Drug product 2011-12-07 N022291-002 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-002 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-002 8052993*PED 2028-02-01 Pediatric extension N022291-002 8052994*PED 2028-02-01 Pediatric extension N022291-002 8062665*PED 2028-02-01 Pediatric extension N022291-002 8071129*PED 2028-02-01 Pediatric extension N022291-002 8828430*PED 2028-02-01 Pediatric extension N022291-003 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-003 7547719*PED 2026-01-13 Pediatric extension N022291-003 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8062665 2027-08-01 U-1306 Drug product 2011-12-07 N022291-003 8062665 2027-08-01 U-2451 Drug product 2011-12-07 N022291-003 8062665 2027-08-01 U-930 Drug product 2011-12-07 N022291-003 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-003 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-003 8052993*PED 2028-02-01 Pediatric extension N022291-003 8052994*PED 2028-02-01 Pediatric extension N022291-003 8062665*PED 2028-02-01 Pediatric extension N022291-003 8071129*PED 2028-02-01 Pediatric extension N022291-003 8828430*PED 2028-02-01 Pediatric extension N022291-004 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-004 7547719*PED 2026-01-13 Pediatric extension N022291-004 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8071129 2027-08-01 U-1306 Drug product 2011-12-21 N022291-004 8071129 2027-08-01 U-2451 Drug product 2011-12-21 N022291-004 8071129 2027-08-01 U-930 Drug product 2011-12-21 N022291-004 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-004 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-004 8052993*PED 2028-02-01 Pediatric extension N022291-004 8052994*PED 2028-02-01 Pediatric extension N022291-004 8062665*PED 2028-02-01 Pediatric extension N022291-004 8071129*PED 2028-02-01 Pediatric extension N022291-004 8828430*PED 2028-02-01 Pediatric extension N022291-005 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-005 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-005 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-005 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 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 79 observed states.
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 N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 7547719*PED 2026-01-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052993 2027-08-01 U-1306 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052993 2027-08-01 U-2451 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052993 2027-08-01 U-930 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052993 2027-08-01 U-1575 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052994 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8062665 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8071129 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8828430 2027-08-01 U-2451 Drug product 2014-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8828430 2027-08-01 U-1306 Drug product 2014-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052993*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8052994*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8062665*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8071129*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-001 8828430*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 7547719*PED 2026-01-13 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052993 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052994 2027-08-01 U-1306 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052994 2027-08-01 U-2451 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052994 2027-08-01 U-930 Drug product 2011-12-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8062665 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8071129 2027-08-01 U-1714 Drug product 2015-07-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8828430 2027-08-01 U-2451 Drug product 2014-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8828430 2027-08-01 U-1306 Drug product 2014-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052993*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8052994*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8062665*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8071129*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-002 8828430*PED 2028-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product 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): 022291 application number: NDA022291