FDA.reportPublic FDA data

ELTROMBOPAG

Product NDC
70771-1925
11-digit product format
707711925
Labeler code
70771
Product ID
70771-1925_5273da92-fa13-4b26-b32f-63955b1983c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eltrombopag
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA216281
Marketing category
ANDA
Marketing start
2026-01-14
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216281-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14
A216281-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14
A216281-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14
A216281-004ELTROMBOPAG 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
A216281-001AB
A216281-002AB
A216281-003AB
A216281-004AB

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 22:54:322026-06A216281-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A216281-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A216281-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-08-01 22:54:322026-06A216281-004ELTROMBOPAG 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 22:54:322026-06A216281-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216281-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A216281-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A216281-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELTROMBOPAGELTROMBOPAGZydus Pharmaceuticals USA Inc.1cfdd1fa-d687-41f9-a160-9491f0beac1e2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216281
application number: ANDA216281
ELTROMBOPAGELTROMBOPAGZydus Lifesciences Limitedae9a7725-64f8-406d-88e7-e6e01136deae2026-01-14Exact identifier
application applno (ANDA): 216281
application number: ANDA216281
ndc (product): 70771-1925

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELTROMBOPAG OLAMINE12.5 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
ae9a7725-64f8-406d-88e7-e6e01136deaeAvailable 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
fa996cde-a51d-4f68-1429-4f06c00a39f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1925-3ELTROMBOPAG30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245001eltrombopag 12.5 MG Oral TabletPSNae9a7725-64f8-406d-88e7-e6e01136deae1
825421eltrombopag 25 MG Oral TabletPSNae9a7725-64f8-406d-88e7-e6e01136deae1
825427eltrombopag 50 MG Oral TabletPSNae9a7725-64f8-406d-88e7-e6e01136deae1
884617eltrombopag 75 MG Oral TabletPSNae9a7725-64f8-406d-88e7-e6e01136deae1
1245001eltrombopag 12.5 MG Oral TabletSCDae9a7725-64f8-406d-88e7-e6e01136deae1
825421eltrombopag 25 MG Oral TabletSCDae9a7725-64f8-406d-88e7-e6e01136deae1
825427eltrombopag 50 MG Oral TabletSCDae9a7725-64f8-406d-88e7-e6e01136deae1
884617eltrombopag 75 MG Oral TabletSCDae9a7725-64f8-406d-88e7-e6e01136deae1
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSYae9a7725-64f8-406d-88e7-e6e01136deae1
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSYae9a7725-64f8-406d-88e7-e6e01136deae1
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSYae9a7725-64f8-406d-88e7-e6e01136deae1
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSYae9a7725-64f8-406d-88e7-e6e01136deae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1925-37077119250330 TABLET in 1 BOTTLE (70771-1925-3) 30 tablet2026-01-14NoNoCurrent