PROMACTA

Product NDC: 0078-0972
11-digit product format: 000780972
Labeler code: 0078
Product ID: 0078-0972_b8a1cc48-9aaf-486a-9305-090acccb5c02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eltrombopag olamine
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA207027
Marketing category: NDA
Marketing start: 2018-09-27
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 1.

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
N207027-001	PROMACTA KIT	ELTROMBOPAG OLAMINE	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24
N207027-002	PROMACTA KIT	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N207027-001	AB
N207027-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21
N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21
N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21
N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21
N207027-001	7547719*PED	2026-01-13		Pediatric extension
N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05
N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05
N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05
N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05
N207027-002	7547719*PED	2026-01-13		Pediatric extension

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.

Product history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2025-01-19 17:59 UTC	2025-01	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2015-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	2025-01	N207027-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207027-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207027-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207027-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207027-002	AB	1	`8072bd15b7f6…`
2026-08-01 22:54:32	2026-06	N207027-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207027-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 826 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC	2025-01	N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-001	7547719*PED	2026-01-13		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	7547719*PED	2026-01-13		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	7547719*PED	2026-01-13		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	7547719*PED	2026-01-13		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	7547719*PED	2026-01-13		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	7547719*PED	2026-01-13		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	7547719*PED	2026-01-13		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	7547719*PED	2026-01-13		Pediatric extension		`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC	2025-01	N207027-001	ODE*	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC	2025-01	N207027-002	ODE*	2025-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	ODE*	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	ODE*	2025-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	ODE*	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	ODE*	2025-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	ODE*	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	ODE*	2025-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207027-001	ODE*	2025-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207027-002	ODE*	2025-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-001	ODE*	2025-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-002	ODE*	2025-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-001	ODE*	2025-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-002	ODE*	2025-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-001	ODE*	2025-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-002	ODE*	2025-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207027-001	ODE*	2025-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207027-002	ODE*	2025-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-001	PED	2022-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-001	ODE*	2025-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-002	PED	2022-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-002	ODE*	2025-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207027-001	PED	2022-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-001	ODE*	2025-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-002	PED	2022-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-002	ODE*	2025-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207027-001	PED	2022-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-001	ODE*	2025-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-002	PED	2022-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-002	ODE*	2025-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207027-001	ODE-74	2021-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207027-001	PED	2022-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207027-001	PED	2022-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207027-001	ODE*	2025-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207027-002	PED	2022-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207027-002	ODE*	2025-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207027-001	ODE-74	2021-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207027-001	PED	2022-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207027-001	ODE*	2025-11-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207027-002	ODE*	2021-08-26	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
PROMACTA	ELTROMBOPAG OLAMINE	Novartis Pharmaceuticals Corporation	7714a0ed-34bb-46e6-a0a5-b363908b22c2	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207027 application number: NDA207027 ndc (product): 0078-0972

Additional Listing Data#

Finished product: Yes
Brand name base: PROMACTA
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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
825421	Internal RxNorm lookup
825425	Internal RxNorm lookup
825427	Internal RxNorm lookup
825429	Internal RxNorm lookup
884617	Internal RxNorm lookup
884619	Internal RxNorm lookup
1245001	Internal RxNorm lookup
1245003	Internal RxNorm lookup
1859498	Internal RxNorm lookup
1859501	Internal RxNorm lookup
2058980	Internal RxNorm lookup
2058981	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
7714a0ed-34bb-46e6-a0a5-b363908b22c2	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0078-0972-61	2023-08-01	C162847	48780-1	0191ceaa-6a00-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use PROMACTA safely and effectively. See full prescribing information for PROMACTA. PROMACTA ® (eltrombopag) tablets, for oral use PROMACTA ® (eltrombopag) for oral suspension Initial U.S. Approval: 2008
0078-0972-61	2023-07-28	C162847	48780-1	0191ceaa-6a00-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use PROMACTA safely and effectively. See full prescribing information for PROMACTA. PROMACTA ® (eltrombopag) tablets, for oral use PROMACTA ® (eltrombopag) for oral suspension Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0972-19	PROMACTA	1 in 1 PACKET	POWDER, FOR SUSPENSION	1	31
0078-0972-23	PROMACTA	30 in 1 CARTON	POWDER, FOR SUSPENSION	30	31
0078-0972-61	PROMACTA	1 in 1 KIT	POWDER, FOR SUSPENSION	1	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0972-19	EA - Each	0078-0972	7d99aa24-1e72-4ad8-87ac-159f65b3d90c	1	2019-02-13
0078-0972-23	EA - Each	0078-0972	9c19e1cb-9ac3-4d93-b383-eb41c3645984	1	2019-02-13
0078-0972-61	EA - Each	0078-0972	98919dbc-a162-4275-8511-2b14a1ec3711	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0972	PROMACTA (ELTROMBOPAG OLAMINE) TABLET, FILM COATED PROMACTA (ELTROMBOPAG OLAMINE) POWDER, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	28	Current NDC, Legacy NDC, 3 package rows	20250105_7714a0ed-34bb-46e6-a0a5-b363908b22c2.zip

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	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
2058980	eltrombopag 12.5 MG Powder for Oral Suspension	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825421	eltrombopag 25 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859498	eltrombopag 25 MG Powder for Oral Suspension	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825427	eltrombopag 50 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884617	eltrombopag 75 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245003	Promacta 12.5 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
2058981	Promacta 12.5 MG Powder for Oral Suspension	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825425	Promacta 25 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859501	Promacta 25 MG Powder for Oral Suspension	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825429	Promacta 50 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884619	Promacta 75 MG Oral Tablet	PSN	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245003	eltrombopag 12.5 MG Oral Tablet [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
2058981	eltrombopag 12.5 MG Powder for Oral Suspension [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825425	eltrombopag 25 MG Oral Tablet [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859501	eltrombopag 25 MG Powder for Oral Suspension [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825429	eltrombopag 50 MG Oral Tablet [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884619	eltrombopag 75 MG Oral Tablet [Promacta]	SBD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245001	eltrombopag 12.5 MG Oral Tablet	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
2058980	eltrombopag 12.5 MG Powder for Oral Suspension	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825421	eltrombopag 25 MG Oral Tablet	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859498	eltrombopag 25 MG Powder for Oral Suspension	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825427	eltrombopag 50 MG Oral Tablet	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884617	eltrombopag 75 MG Oral Tablet	SCD	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245001	eltrombopag (as eltrombopag olamine) 12.5 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825421	eltrombopag (as eltrombopag olamine) 25 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859498	eltrombopag (as eltrombopag olamine) 25 MG Powder for Oral Suspension	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825427	eltrombopag (as eltrombopag olamine) 50 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884617	eltrombopag (as eltrombopag olamine) 75 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245003	Promacta (as eltrombopag olamine) 12.5 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
2058981	Promacta (as eltrombopag olamine) 12.5 MG Powder for Oral Suspension	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825425	Promacta (as eltrombopag olamine) 25 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825429	Promacta (as eltrombopag olamine) 50 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884619	Promacta (as eltrombopag olamine) 75 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1245003	Promacta 12.5 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825425	Promacta 25 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859501	Promacta 25 MG Powder for Oral Suspension	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
825429	Promacta 50 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
884619	Promacta 75 MG Oral Tablet	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31
1859501	Promacta eltrombopag 25 MG (as eltrombopag olamine) Powder for Oral Suspension	SY	7714a0ed-34bb-46e6-a0a5-b363908b22c2	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0972-19	00078097219	1 in 1 PACKET						Historical
0078-0972-23	00078097223	30 in 1 CARTON						Historical
0078-0972-61	00078097261	1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)	1 carton	2018-09-27	0000-00-00	No	No	Current