FDA.reportPublic FDA data

Eltrombopag Olamine

Product NDC
42291-934
Requested package NDC
42291-934-30
11-digit product format
422910934
Labeler code
42291
Product ID
42291-934_52450258-e1d1-ea75-e063-6394a90a0435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eltrombopag
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA212884
Marketing category
ANDA
Marketing start
2026-02-16
Substance
ELTROMBOPAG OLAMINE
Active strength
50 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212884-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14
A212884-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14
A212884-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14
A212884-004ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A212884-001AB
A212884-002AB
A212884-003AB
A212884-004AB

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
2026-08-01 22:54:322026-06A212884-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A212884-002ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A212884-003ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A212884-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212884-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212884-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A212884-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A212884-004AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eltrombopag OlamineELTROMBOPAGAvKARE4af8f855-f710-e96f-e063-6294a90abb462026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212884
application number: ANDA212884
ndc (package): 42291-934-30
ndc (product): 42291-934
ndc11 (package): 42291093430
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLCc97337c3-d758-40a3-a1ef-fd122f15e8212025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212884
application number: ANDA212884
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLC05acf38e-7870-4809-a045-fc38e66b11102025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212884
application number: ANDA212884

Additional Listing Data#

Finished product
Yes
Brand name base
Eltrombopag Olamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG OLAMINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4U07F515LGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
825421Internal RxNorm lookup
825427Internal RxNorm lookup
884617Internal RxNorm lookup
1245001Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4af8f855-f710-e96f-e063-6294a90abb46Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
349df11e-99eb-4fff-8cd5-538adda21b14Product name320251110
4db6dd95-5e83-4752-b5e1-62f824423c50Product name120241217
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-934-30Eltrombopag Olamine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-934-30EA - Each42291-934cd55b5d1-0222-4c85-96ee-6282f7c0d74812026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag 25 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag 50 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag 75 MG Oral TabletPSN4af8f855-f710-e96f-e063-6294a90abb462
1245001eltrombopag 12.5 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag 25 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag 50 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag 75 MG Oral TabletSCD4af8f855-f710-e96f-e063-6294a90abb462
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY4af8f855-f710-e96f-e063-6294a90abb462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-934-304229109343030 TABLET, FILM COATED in 1 BOTTLE (42291-934-30) 2026-02-16NoNoCurrent