Home NDC 0054-0962 Eltrombopag
Product NDC 0054-0962
11-digit product format 000540962
Labeler code 0054
Product ID 0054-0962_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 12.5 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 1 .
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 2026-07-26 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# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220033-004 AB 1 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 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): 0054-0962
Additional Listing Data#
Finished product Yes
Brand name base Eltrombopag
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELTROMBOPAG OLAMINE 12.5 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 0054-0962-13 Eltrombopag 30 in 1 BOTTLE TABLET 30 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0962-13 00054096213 30 TABLET in 1 BOTTLE (0054-0962-13) 30 tablet 2026-04-24 No No Current