Home NDC 60219-1416 Eltrombopag Olamine
Product NDC 60219-1416
11-digit product format 602191416
Labeler code 60219
Product ID 60219-1416_992e50d5-b6c2-4213-9c7c-ef25c84d0708
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eltrombopag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212884
Marketing category ANDA
Marketing start 2026-01-15
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 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 A212884-001 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-01-14 A212884-002 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-01-14 A212884-003 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-01-14 A212884-004 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-01-14
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 2026-02-19 14:30 UTC 2026-02 A212884-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212884-002 ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212884-003 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212884-004 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-01-14 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212884-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-01-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212884-002 ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB 2026-01-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212884-003 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-01-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212884-004 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-01-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Eltrombopag Olamine
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 60219-1416-3 Eltrombopag Olamine 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 13
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60219-1416-3 60219141603 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-1416-3) 2026-01-15 No No Current