Eltrombopag

Product NDC: 31722-300
11-digit product format: 317220300
Labeler code: 31722
Product ID: 31722-300_315730ec-c40c-af1a-e063-6294a90a010f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eltrombopag olamine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA216620
Marketing category: ANDA
Marketing start: 2025-05-13
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216620-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB		2024-04-18
A216620-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB		2024-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216620-001	AB
A216620-002	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
2026-08-18 06:07:40	2026-07	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216620-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216620-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	2024-04-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216620-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216620-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216620-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216620-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216620-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216620-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216620-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216620-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216620-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216620-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216620-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216620-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216620-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216620-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216620-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216620-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216620-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216620-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216620-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-001	PC	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216620-002	PC	2025-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216620-001	PC	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216620-002	PC	2025-11-09	`6a471c1ec25d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Eltrombopag
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ELTROMBOPAG OLAMINE	12.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1859498	Internal RxNorm lookup
2058980	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
8f6499f0-4774-4f1e-8ab5-145c1fe64401	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
fa996cde-a51d-4f68-1429-4f06c00a39f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-300-12	Eltrombopag	1 in 1 PACKET	POWDER, FOR SUSPENSION	1	1
31722-300-31	Eltrombopag	30 in 1 CARTON	POWDER, FOR SUSPENSION	30	1
31722-300-32	Eltrombopag	1 in 1 KIT	POWDER, FOR SUSPENSION	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-300-12	EA - Each	31722-300	d2b4fd99-471c-44b8-adc2-452f727fca08	1	2025-06-13
31722-300-32	EA - Each	31722-300	b1381e77-1163-49aa-8057-f44918af538a	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-300	ELTROMBOPAG (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.]	1	Current NDC, 3 package rows	20250514_8f6499f0-4774-4f1e-8ab5-145c1fe64401.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eltrombopag	ELTROMBOPAG OLAMINE	Camber Pharmaceuticals, Inc.	8f6499f0-4774-4f1e-8ab5-145c1fe64401	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216620 application number: ANDA216620 ndc (product): 31722-300

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
2058980	eltrombopag 12.5 MG Powder for Oral Suspension	PSN	8f6499f0-4774-4f1e-8ab5-145c1fe64401	1
1859498	eltrombopag 25 MG Powder for Oral Suspension	PSN	8f6499f0-4774-4f1e-8ab5-145c1fe64401	1
2058980	eltrombopag 12.5 MG Powder for Oral Suspension	SCD	8f6499f0-4774-4f1e-8ab5-145c1fe64401	1
1859498	eltrombopag 25 MG Powder for Oral Suspension	SCD	8f6499f0-4774-4f1e-8ab5-145c1fe64401	1
1859498	eltrombopag (as eltrombopag olamine) 25 MG Powder for Oral Suspension	SY	8f6499f0-4774-4f1e-8ab5-145c1fe64401	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
31722-300-12	31722030012	1 in 1 PACKET					Historical
31722-300-31	31722030031	30 in 1 CARTON					Historical
31722-300-32	31722030032	1 CARTON in 1 KIT (31722-300-32) / 30 PACKET in 1 CARTON (31722-300-31) / 1 POWDER, FOR SUSPENSION in 1 PACKET (31722-300-12)	1 carton	2025-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eltrombopag	Camber Pharmaceuticals, Inc. \| Annora Pharma Private Limited	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	1