Home NDC 0078-0687 PROMACTA
Product NDC 0078-0687
11-digit product format 000780687
Labeler code 0078
Product ID 0078-0687_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 2016-04-01
Substance ELTROMBOPAG OLAMINE
Active strength 75 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 · 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PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16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.
Product history page 1 of 5 · 200 observed 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 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 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 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 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 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 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 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 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 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 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 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 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 d8e5a09893c0…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 113 · 4,488 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 7547719*PED 2026-01-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052993 2027-08-01 U-1306 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052993 2027-08-01 U-2451 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052993 2027-08-01 U-930 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052993 2027-08-01 U-1575 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052994 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8062665 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8071129 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8828430 2027-08-01 U-2451 Drug product 2014-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8828430 2027-08-01 U-1306 Drug product 2014-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052993*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8052994*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8062665*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8071129*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 8828430*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 7547719*PED 2026-01-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052993 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052994 2027-08-01 U-1306 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052994 2027-08-01 U-2451 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052994 2027-08-01 U-930 Drug product 2011-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8062665 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8071129 2027-08-01 U-1714 Drug product 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8828430 2027-08-01 U-2451 Drug product 2014-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8828430 2027-08-01 U-1306 Drug product 2014-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052993*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8052994*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8062665*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8071129*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 8828430*PED 2028-02-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 9 · 330 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-004 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-005 ODE-210 2025-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022291-001 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-002 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-003 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-004 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-005 ODE-210 2025-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-001 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-002 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-003 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-004 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-005 ODE-210 2025-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-001 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-002 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-003 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-004 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-005 ODE-210 2025-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-001 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-002 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-003 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-004 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-005 ODE-210 2025-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-001 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-002 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-003 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-004 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-005 ODE-210 2025-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-001 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-002 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-003 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-004 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-005 ODE-210 2025-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-001 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-002 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-003 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-004 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-005 ODE-210 2025-11-16 d8e5a09893c0…
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 ndc (product): 0078-0687
Additional Listing Data#
Finished product Yes
Brand name base PROMACTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELTROMBOPAG OLAMINE 75 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 0078-0687-15 PROMACTA 30 in 1 BOTTLE TABLET, FILM COATED 30 31
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0687 PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 28 Current NDC, Legacy NDC, 1 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 Marketing start Marketing end Sample Exclude flag Status 0078-0687-15 00078068715 30 TABLET, FILM COATED in 1 BOTTLE (0078-0687-15) 2016-04-01 0000-00-00 No No Current