PROMACTA

Product NDC: 0007-4641
11-digit product format: 000074641
Labeler code: 0007
Product ID: 0007-4641_c7c46a73-1f77-45f6-ab60-1aa8f9e87463
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eltrombopag olamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA022291
Marketing category: NDA
Marketing start: 2008-11-24
Marketing end: 2019-04-30
Substance: ELTROMBOPAG OLAMINE
Active strength: 50 mg/1
Pharmacologic classes: Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0007-4641		D	Discontinued by firm	2026-08-17
excluded package	package	0007-4641	0007-4641-13	D	Discontinued by firm	2026-08-17
excluded package	package	0007-4641	0007-4641-61	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0007-4641-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0007-4641-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0007-4641-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0007-4641-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0007-4641-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0007-4641-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0007-4641-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0007-4641-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0007-4641-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0007-4641-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0007-4641-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0007-4641-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0007-4641-61	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0007-4641-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0007-4641-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0007-4641-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0007-4641-61	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0007-4641-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0007-4641-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0007-4641-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0007-4641-61	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0007-4641-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0007-4641-61	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0007-4641-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022291-001	PROMACTA	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20
N022291-002	PROMACTA	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20
N022291-003	PROMACTA	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08
N022291-004	PROMACTA	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20
N022291-005	PROMACTA	ELTROMBOPAG OLAMINE	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022291-001	AB
N022291-002	AB
N022291-003	AB
N022291-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N022291-001	7547719	2025-07-13	U-1306	Drug substance, Drug product
N022291-001	7547719	2025-07-13	U-1575	Drug substance, Drug product
N022291-001	7547719	2025-07-13	U-2451	Drug substance, Drug product
N022291-001	7547719	2025-07-13	U-2452	Drug substance, Drug product
N022291-001	7547719*PED	2026-01-13		Pediatric extension
N022291-002	7547719	2025-07-13	U-1306	Drug substance, Drug product
N022291-002	7547719	2025-07-13	U-1575	Drug substance, Drug product
N022291-002	7547719	2025-07-13	U-2451	Drug substance, Drug product
N022291-002	7547719	2025-07-13	U-2452	Drug substance, Drug product
N022291-002	7547719	2025-07-13	U-930	Drug substance, Drug product
N022291-002	7547719*PED	2026-01-13		Pediatric extension
N022291-003	7547719	2025-07-13	U-1306	Drug substance, Drug product
N022291-003	7547719	2025-07-13	U-1575	Drug substance, Drug product
N022291-003	7547719	2025-07-13	U-2451	Drug substance, Drug product
N022291-003	7547719	2025-07-13	U-2452	Drug substance, Drug product
N022291-003	7547719	2025-07-13	U-930	Drug substance, Drug product
N022291-003	7547719*PED	2026-01-13		Pediatric extension
N022291-004	7547719	2025-07-13	U-1306	Drug substance, Drug product
N022291-004	7547719	2025-07-13	U-1575	Drug substance, Drug product
N022291-004	7547719	2025-07-13	U-2451	Drug substance, Drug product
N022291-004	7547719	2025-07-13	U-2452	Drug substance, Drug product
N022291-004	7547719*PED	2026-01-13		Pediatric extension
N022291-005	7547719	2025-07-13	U-1306	Drug substance, Drug product
N022291-005	7547719	2025-07-13	U-1575	Drug substance, Drug product
N022291-005	7547719	2025-07-13	U-930	Drug substance, Drug product
N022291-005	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 6 · 210 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
2026-08-18 06:07:40	2026-07	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL	AB	RLD	2008-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL	AB	RLD, RS	2009-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL	AB	RLD	2011-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL		RLD	2008-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL		RLD	2008-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL		RLD, RS	2009-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL		RLD	2011-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-001	PROMACTA	EQ 25MG ACID	TABLET / ORAL		RLD	2008-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-002	PROMACTA	EQ 50MG ACID	TABLET / ORAL		RLD	2008-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-003	PROMACTA	EQ 75MG ACID	TABLET / ORAL		RLD, RS	2009-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-004	PROMACTA	EQ 12.5MG ACID	TABLET / ORAL		RLD	2011-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-005	PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2012-11-16	`2680178bc6a6…`

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	N022291-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022291-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022291-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-004	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022291-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022291-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022291-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022291-004	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 115 · 4,593 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022291-001	7547719	2025-07-13	U-2451	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-001	7547719	2025-07-13	U-2452	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-001	7547719	2025-07-13	U-1575	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-001	7547719	2025-07-13	U-1306	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-001	7547719*PED	2026-01-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719	2025-07-13	U-1575	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719	2025-07-13	U-2452	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719	2025-07-13	U-1306	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719	2025-07-13	U-930	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719	2025-07-13	U-2451	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-002	7547719*PED	2026-01-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719	2025-07-13	U-2451	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719	2025-07-13	U-1575	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719	2025-07-13	U-930	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719	2025-07-13	U-1306	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719	2025-07-13	U-2452	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-003	7547719*PED	2026-01-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	7547719	2025-07-13	U-2451	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	7547719	2025-07-13	U-1575	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	7547719	2025-07-13	U-2452	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	7547719	2025-07-13	U-1306	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-004	7547719*PED	2026-01-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-005	7547719	2025-07-13	U-1575	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-005	7547719	2025-07-13	U-930	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-005	7547719	2025-07-13	U-1306	Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022291-005	7547719*PED	2026-01-13		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022291-001	7547719	2025-07-13	U-2451	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	7547719	2025-07-13	U-2452	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	7547719	2025-07-13	U-1575	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	7547719	2025-07-13	U-1306	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	7547719*PED	2026-01-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8052993	2027-08-01	U-1306	Drug product	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8052993	2027-08-01	U-2451	Drug product	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8052993	2027-08-01	U-930	Drug product	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8052993	2027-08-01	U-1575	Drug product	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8052994	2027-08-01	U-1714	Drug product	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8062665	2027-08-01	U-1714	Drug product	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8071129	2027-08-01	U-1714	Drug product	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8828430	2027-08-01	U-2451	Drug product	2014-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022291-001	8828430	2027-08-01	U-1306	Drug product	2014-10-07	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 330 observed states.

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	N022291-001	ODE-210	2025-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-002	ODE-210	2025-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-003	ODE-210	2025-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-004	ODE-210	2025-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022291-005	ODE-210	2025-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022291-001	ODE-210	2025-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-002	ODE-210	2025-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-003	ODE-210	2025-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-004	ODE-210	2025-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022291-005	ODE-210	2025-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-001	ODE-210	2025-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-002	ODE-210	2025-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-003	ODE-210	2025-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-004	ODE-210	2025-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022291-005	ODE-210	2025-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-001	ODE-210	2025-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-002	ODE-210	2025-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-003	ODE-210	2025-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-004	ODE-210	2025-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022291-005	ODE-210	2025-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-001	ODE-210	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-002	ODE-210	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-003	ODE-210	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-004	ODE-210	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022291-005	ODE-210	2025-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-001	ODE-210	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-002	ODE-210	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-003	ODE-210	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-004	ODE-210	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022291-005	ODE-210	2025-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022291-001	ODE-210	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022291-002	ODE-210	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022291-003	ODE-210	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022291-004	ODE-210	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022291-005	ODE-210	2025-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022291-001	ODE-210	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022291-002	ODE-210	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022291-003	ODE-210	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022291-004	ODE-210	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022291-005	ODE-210	2025-11-16	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0007-4641-13	EA - Each	0007-4641	a69cbb9f-d349-4cb3-a6a4-3fc649b66fe6	1	2012-07-24

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
PROMACTA	ELTROMBOPAG OLAMINE	Novartis Pharmaceuticals Corporation	7714a0ed-34bb-46e6-a0a5-b363908b22c2	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022291 application number: NDA022291