Eltrombopag olamine

Product NDC: 87564-035
Requested package NDC: 87564-035-30
11-digit product format: 875640035
Labeler code: 87564
Product ID: 87564-035_5579564f-8f5f-9071-e063-6294a90a777e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eltrombopag olamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amerisyn, LLC
Application: ANDA219638
Marketing category: ANDA
Marketing start: 2026-06-30
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A219638-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14
A219638-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14
A219638-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14
A219638-004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219638-001	AB
A219638-002	AB
A219638-003	AB
A219638-004	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	A219638-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219638-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219638-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`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	A219638-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219638-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219638-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219638-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219638-004	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219638-004	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 olamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ELTROMBOPAG OLAMINE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4U07F515LG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
52ba8e06-aa7d-caa6-e063-6294a90a5ce5	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eltrombopag olamine	ELTROMBOPAG OLAMINE	Amerisyn, LLC	52ba8e06-aa7d-caa6-e063-6294a90a5ce5	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219638 application number: ANDA219638 ndc (package): 87564-035-30 ndc (product): 87564-035 ndc11 (package): 87564003530
Eltrombopag olamine	ELTROMBOPAG OLAMINE	Somerset Therapeutics, LLC	604f663c-4933-402a-8105-5921713cf3c8	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219638 application number: ANDA219638

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87564-035-30	87564003530	30 TABLET, FILM COATED in 1 BOTTLE (87564-035-30)	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eltrombopag olamine	Amerisyn, LLC \| Somerset Therapeutics, LLC \| Synthon Hispania S.L. \| Havix Group Inc d/b/a Aavis Pharmaceuticals	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	2