Home NDC 0480-4015 Eltrombopag
Product NDC 0480-4015
11-digit product format 004804015
Labeler code 0480
Product ID 0480-4015_6cd00417-19b9-447d-bbba-f2ebfb1169c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eltrombopag
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209938
Marketing category ANDA
Marketing start 2026-09-17
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209938-001 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-07-13 A209938-002 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-07-13 A209938-003 ELTROMBOPAG OLAMINE ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-09-14 22:38:34 2026-08 A209938-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209938-002 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209938-003 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209938-001 ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209938-002 ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB 2026-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209938-003 ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB 2026-07-13 caaa826d4ba7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-4015-56 00480401556 30 TABLET, FILM COATED in 1 BOTTLE (0480-4015-56) 2026-09-17 No No Current