Eltrombopag Olamine

Product NDC: 69238-1414
Requested package NDC: 69238-1414-3
11-digit product format: 692381414
Labeler code: 69238
Product ID: 69238-1414_8dba449a-e27a-4f76-a831-6774aa89c217
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eltrombopag
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA212884
Marketing category: ANDA
Marketing start: 2026-01-15
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
A212884-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14
A212884-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14
A212884-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14
A212884-004	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
A212884-001	AB
A212884-002	AB
A212884-003	AB
A212884-004	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	A212884-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-002	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-003	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212884-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-002	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-003	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212884-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-002	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-003	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-004	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	A212884-001	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	A212884-002	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	A212884-003	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	A212884-004	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	A212884-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212884-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212884-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212884-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212884-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212884-004	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212884-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212884-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212884-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212884-004	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
c97337c3-d758-40a3-a1ef-fd122f15e821	Available on FDA.report

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
69238-1414-3	Eltrombopag Olamine	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eltrombopag Olamine	ELTROMBOPAG	AvKARE	4af8f855-f710-e96f-e063-6294a90abb46	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212884 application number: ANDA212884
Eltrombopag Olamine	ELTROMBOPAG	Amneal Pharmaceuticals NY LLC	c97337c3-d758-40a3-a1ef-fd122f15e821	2025-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212884 application number: ANDA212884 ndc (package): 69238-1414-3 ndc (product): 69238-1414 ndc11 (package): 69238141403
Eltrombopag Olamine	ELTROMBOPAG	Amneal Pharmaceuticals NY LLC	05acf38e-7870-4809-a045-fc38e66b1110	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212884 application number: ANDA212884

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4U07F515LG	ELTROMBOPAG OLAMINE	496775-62-3	ELTROMBOPAG OLAMINE
S56D65XJ9G	ELTROMBOPAG	496775-61-2	Eltrombopag

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245001	eltrombopag 12.5 MG Oral Tablet	PSN	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825421	eltrombopag 25 MG Oral Tablet	PSN	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825427	eltrombopag 50 MG Oral Tablet	PSN	c97337c3-d758-40a3-a1ef-fd122f15e821	4
884617	eltrombopag 75 MG Oral Tablet	PSN	c97337c3-d758-40a3-a1ef-fd122f15e821	4
1245001	eltrombopag 12.5 MG Oral Tablet	SCD	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825421	eltrombopag 25 MG Oral Tablet	SCD	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825427	eltrombopag 50 MG Oral Tablet	SCD	c97337c3-d758-40a3-a1ef-fd122f15e821	4
884617	eltrombopag 75 MG Oral Tablet	SCD	c97337c3-d758-40a3-a1ef-fd122f15e821	4
1245001	eltrombopag (as eltrombopag olamine) 12.5 MG Oral Tablet	SY	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825421	eltrombopag (as eltrombopag olamine) 25 MG Oral Tablet	SY	c97337c3-d758-40a3-a1ef-fd122f15e821	4
825427	eltrombopag (as eltrombopag olamine) 50 MG Oral Tablet	SY	c97337c3-d758-40a3-a1ef-fd122f15e821	4
884617	eltrombopag (as eltrombopag olamine) 75 MG Oral Tablet	SY	c97337c3-d758-40a3-a1ef-fd122f15e821	4
1245001	eltrombopag 12.5 MG Oral Tablet	PSN	4af8f855-f710-e96f-e063-6294a90abb46	2
825421	eltrombopag 25 MG Oral Tablet	PSN	4af8f855-f710-e96f-e063-6294a90abb46	2
825427	eltrombopag 50 MG Oral Tablet	PSN	4af8f855-f710-e96f-e063-6294a90abb46	2
884617	eltrombopag 75 MG Oral Tablet	PSN	4af8f855-f710-e96f-e063-6294a90abb46	2
1245001	eltrombopag 12.5 MG Oral Tablet	SCD	4af8f855-f710-e96f-e063-6294a90abb46	2
825421	eltrombopag 25 MG Oral Tablet	SCD	4af8f855-f710-e96f-e063-6294a90abb46	2
825427	eltrombopag 50 MG Oral Tablet	SCD	4af8f855-f710-e96f-e063-6294a90abb46	2
884617	eltrombopag 75 MG Oral Tablet	SCD	4af8f855-f710-e96f-e063-6294a90abb46	2
1245001	eltrombopag (as eltrombopag olamine) 12.5 MG Oral Tablet	SY	4af8f855-f710-e96f-e063-6294a90abb46	2
825421	eltrombopag (as eltrombopag olamine) 25 MG Oral Tablet	SY	4af8f855-f710-e96f-e063-6294a90abb46	2
825427	eltrombopag (as eltrombopag olamine) 50 MG Oral Tablet	SY	4af8f855-f710-e96f-e063-6294a90abb46	2
884617	eltrombopag (as eltrombopag olamine) 75 MG Oral Tablet	SY	4af8f855-f710-e96f-e063-6294a90abb46	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69238-1414-3	69238141403	30 TABLET, FILM COATED in 1 BOTTLE (69238-1414-3)	2026-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eltrombopag Olamine	AvKARE	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	2
Eltrombopag Olamine	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	4