PRASUGREL

Product NDC: 67877-604
11-digit product format: 678770604
Labeler code: 67877
Product ID: 67877-604_d09e39d8-259f-e46d-e053-2a95a90ad97f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prasugrel
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA205790
Marketing category: ANDA
Marketing start: 2017-10-17
Marketing end: 0000-00-00
Substance: PRASUGREL HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67877-604		I	Inactivated by FDA		2026-08-17
excluded package	package	67877-604	67877-604-30	I	Inactivated by FDA		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 · 30 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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`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	67877-604-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67877-604-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67877-604-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67877-604-30	`1332a3947898…`	`d4bfe170f9cd…`

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
A205790-001	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL			2017-10-16
A205790-002	PRASUGREL	PRASUGREL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL			2017-10-16

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 3 · 84 observed 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	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL		2017-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL		2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205790-001	PRASUGREL	EQ 5MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205790-002	PRASUGREL	EQ 10MG BASE	TABLET / ORAL	AB	2017-10-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A205790-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205790-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205790-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205790-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205790-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205790-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205790-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205790-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205790-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205790-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205790-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205790-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205790-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205790-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205790-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205790-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205790-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205790-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205790-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205790-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205790-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205790-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205790-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205790-002	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b7c49f42-bd3a-58c0-797d-351eed22235a	Product name	8	20250616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-604-30	2023-01-30	C162847	48780-1	c7ccaba7-12a2-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
67877-604-30	2021-11-12	C162847	48780-1	c7ccaba7-12a2-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009
67877-604-30	2021-07-23	C162847	48780-1	c7ccaba7-12a2-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use PRASUGREL TABLETS safely and effectively. See full prescribing information for PRASUGREL TABLETS. PRASUGREL tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-604-30	PRASUGREL	30 in 1 BOTTLE	TABLET, FILM COATED	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-604-30	EA - Each	67877-604	3e22cfea-b621-49d4-a461-cf32fd973f51	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-604	PRASUGREL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	6	Legacy NDC, 1 package rows	20211113_85c41426-e3a4-4133-8328-e0367693a9c9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G89JQ59I13	PRASUGREL HYDROCHLORIDE	389574-19-0	PRASUGREL HYDROCHLORIDE
34K66TBT99	PRASUGREL	150322-43-3	Prasugrel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855812	prasugrel 10 MG Oral Tablet	PSN	85c41426-e3a4-4133-8328-e0367693a9c9	6
855818	prasugrel 5 MG Oral Tablet	PSN	85c41426-e3a4-4133-8328-e0367693a9c9	6
855812	prasugrel 10 MG Oral Tablet	SCD	85c41426-e3a4-4133-8328-e0367693a9c9	6
855818	prasugrel 5 MG Oral Tablet	SCD	85c41426-e3a4-4133-8328-e0367693a9c9	6
855812	prasugrel (as prasugrel HCl 10.98 MG) 10 MG Oral Tablet	SY	85c41426-e3a4-4133-8328-e0367693a9c9	6
855818	prasugrel (as prasugrel HCl 5.49 MG ) 5 MG Oral Tablet	SY	85c41426-e3a4-4133-8328-e0367693a9c9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-604-30	67877060430	30 TABLET, FILM COATED in 1 BOTTLE (67877-604-30)	2017-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRASUGREL	Ascend Laboratories, LLC	2021-11-12	HUMAN PRESCRIPTION DRUG LABEL	6
PRASUGREL	Liberty Pharmaceuticals, Inc. \| Proficient Rx LP	2019-08-01	HUMAN PRESCRIPTION DRUG LABEL	1