FDA.reportPublic FDA data

Eltrombopag

Product NDC
0480-4031
11-digit product format
004804031
Labeler code
0480
Product ID
0480-4031_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
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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209938-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-13
A209938-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-13
A209938-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209938-001AB
A209938-002AB
A209938-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209938-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A209938-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A209938-003ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A209938-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-003ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209938-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209938-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209938-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A209938-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-003AB1caaa826d4ba7…

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
IngredientStrength
ELTROMBOPAG OLAMINE75 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-4031-560048040315630 TABLET, FILM COATED in 1 BOTTLE (0480-4031-56) 2026-09-17NoNoCurrent