FDA.reportPublic FDA data

ELTROMBOPAG tablets, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-01-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:55:49

Label at a glance#

ProductELTROMBOPAG
Active ingredientELTROMBOPAG OLAMINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1925-3

Eltrombopag Tablets, 12.5 mg

30 Tablets

Rx only

12.5 mg
12.5 mg

NDC 70771-1926-3

Eltrombopag Tablets, 25 mg

30 Tablets

Rx only

25 mg
25 mg

NDC 70771-1927-3

Eltrombopag Tablets, 50 mg

30 Tablets

Rx only

50 mg
50 mg

NDC 70771-1928-3

Eltrombopag Tablets, 75 mg

30 Tablets

Rx only

75 mg
75 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245001eltrombopag 12.5 MG Oral TabletPSN1
825421eltrombopag 25 MG Oral TabletPSN1
825427eltrombopag 50 MG Oral TabletPSN1
884617eltrombopag 75 MG Oral TabletPSN1
1245001eltrombopag 12.5 MG Oral TabletSCD1
825421eltrombopag 25 MG Oral TabletSCD1
825427eltrombopag 50 MG Oral TabletSCD1
884617eltrombopag 75 MG Oral TabletSCD1
1245001eltrombopag (as eltrombopag olamine) 12.5 MG Oral TabletSY1
825421eltrombopag (as eltrombopag olamine) 25 MG Oral TabletSY1
825427eltrombopag (as eltrombopag olamine) 50 MG Oral TabletSY1
884617eltrombopag (as eltrombopag olamine) 75 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ELTROMBOPAG Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
70771-1926-3ELTROMBOPAG30 in 1 BOTTLETABLET301
70771-1927-3ELTROMBOPAG30 in 1 BOTTLETABLET301
70771-1927-7ELTROMBOPAG14 in 1 BOTTLETABLET141
70771-1928-3ELTROMBOPAG30 in 1 BOTTLETABLET301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-192570771-1925-3
70771-192670771-1926-3
70771-192770771-1927-7, 70771-1927-3
70771-192870771-1928-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
ELTROMBOPAG OLAMINE4U07F515LGACTIM
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
ELTROMBOPAG OLAMINE4U07F515LGACTIM
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
ELTROMBOPAG OLAMINE4U07F515LGACTIM
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
ELTROMBOPAG OLAMINE4U07F515LGACTIM
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:342026-08A216281-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08A216281-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08A216281-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-1484e616aacf4f…
2026-09-14 22:38:342026-08A216281-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-1484e616aacf4f…
2026-08-18 06:07:402026-07A216281-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216281-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-14011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216281-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216281-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216281-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A216281-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A216281-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216281-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216281-004AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216281-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELTROMBOPAGELTROMBOPAGZydus Lifesciences Limitedae9a7725-64f8-406d-88e7-e6e01136deae2026-01-14Exact identifier
ndc (package): 70771-1926-3
ndc (package): 70771-1928-3
ndc (package): 70771-1927-7
ndc (package): 70771-1925-3
ndc (package): 70771-1927-3
ndc (product): 70771-1927
ndc (product): 70771-1928
ndc (product): 70771-1925
ndc (product): 70771-1926
ndc11 (package): 70771192603
ndc11 (package): 70771192707
ndc11 (package): 70771192703
ndc11 (package): 70771192503
ndc11 (package): 70771192803
spl id: 5273da92-fa13-4b26-b32f-63955b1983c3
spl set id: ae9a7725-64f8-406d-88e7-e6e01136deae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.