Home NDC 0054-0963 Eltrombopag
Product NDC 0054-0963
11-digit product format 000540963
Labeler code 0054
Product ID 0054-0963_64b1a316-d824-44b2-a0c6-785001e11c82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eltrombopag Olamine
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA220033
Marketing category ANDA
Marketing start 2026-04-24
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220033-001 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-04-08 A220033-002 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-04-08 A220033-003 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-04-08 A220033-004 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 2026-08-18 06:07:40 2026-07 A220033-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220033-002 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220033-003 ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220033-004 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-04-08 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-04-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-002 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-04-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-003 ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-04-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-004 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-04-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Eltrombopag
Listing expiration 2027-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 825421 Internal RxNorm lookup 825427 Internal RxNorm lookup 884617 Internal RxNorm lookup 1245001 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0963-13 Eltrombopag 30 in 1 BOTTLE TABLET 30 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 Eltrombopag ELTROMBOPAG OLAMINE Hikma Pharmaceuticals USA Inc. 20e91f76-06a8-4ab7-86c7-1df29850b5bd 2026-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 220033 application number: ANDA220033 ndc (product): 0054-0963
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0963-13 00054096313 30 TABLET in 1 BOTTLE (0054-0963-13) 30 tablet 2026-04-24 No No Current