Eltrombopag

Product NDC: 0054-0962
11-digit product format: 000540962
Labeler code: 0054
Product ID: 0054-0962_ad54ce7f-4714-48d1-b511-6be0b11838f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eltrombopag Olamine
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA220033
Marketing category: ANDA
Marketing start: 2026-04-24
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A220033-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-04-08
A220033-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-04-08
A220033-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-04-08
A220033-004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220033-001	AB
A220033-002	AB
A220033-003	AB
A220033-004	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A220033-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-04-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220033-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-04-08	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A220033-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220033-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220033-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220033-004	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220033-004	AB	1	`a50c72e98297…`

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
349df11e-99eb-4fff-8cd5-538adda21b14	Product name	3	20251110
4db6dd95-5e83-4752-b5e1-62f824423c50	Product name	1	20241217
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
fa996cde-a51d-4f68-1429-4f06c00a39f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0962-13	Eltrombopag	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0962-13	EA - Each	0054-0962	7065ead9-65aa-485b-97e8-35e2f000e515	1	2026-05-22

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4U07F515LG	ELTROMBOPAG OLAMINE	496775-62-3	ELTROMBOPAG OLAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245001	eltrombopag 12.5 MG Oral Tablet	PSN	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825421	eltrombopag 25 MG Oral Tablet	PSN	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825427	eltrombopag 50 MG Oral Tablet	PSN	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
884617	eltrombopag 75 MG Oral Tablet	PSN	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
1245001	eltrombopag 12.5 MG Oral Tablet	SCD	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825421	eltrombopag 25 MG Oral Tablet	SCD	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825427	eltrombopag 50 MG Oral Tablet	SCD	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
884617	eltrombopag 75 MG Oral Tablet	SCD	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
1245001	eltrombopag (as eltrombopag olamine) 12.5 MG Oral Tablet	SY	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825421	eltrombopag (as eltrombopag olamine) 25 MG Oral Tablet	SY	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
825427	eltrombopag (as eltrombopag olamine) 50 MG Oral Tablet	SY	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2
884617	eltrombopag (as eltrombopag olamine) 75 MG Oral Tablet	SY	20e91f76-06a8-4ab7-86c7-1df29850b5bd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0054-0962-13	00054096213	30 TABLET in 1 BOTTLE (0054-0962-13)	30 tablet	2026-04-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eltrombopag	Hikma Pharmaceuticals USA Inc. \| Zenara Pharma Private Limited	2026-09-11	HUMAN PRESCRIPTION DRUG LABEL	3