AGGRASTAT

Product NDC: 25208-002
11-digit product format: 252080002
Labeler code: 25208
Product ID: 25208-002_6fae214d-f37d-49ff-b1bb-266584eb664f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TIROFIBAN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medicure International Inc
Application: NDA020913
Marketing category: NDA
Marketing start: 1998-05-14
Substance: TIROFIBAN HYDROCHLORIDE
Active strength: 5 mg/100mL
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	25208-002	25208-002-03	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020913-001	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14
N020913-002	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17
N020913-003	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020913-002	AP
N020913-003	AP

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 4 · 126 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	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020913-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020913-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020913-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020913-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020913-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020913-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020913-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020913-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020913-003	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020913-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020913-003	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020913-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020913-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020913-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020913-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020913-002	AP	1	`ea1830bbd6c7…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-001	6770660	2023-05-01	U-1444		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-002	6770660	2023-05-01	U-1444		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020913-001	6770660	2023-05-01	U-1444		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020913-002	6770660	2023-05-01	U-1444		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020913-001	6770660	2023-05-01	U-1444		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020913-002	6770660	2023-05-01	U-1444		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020913-001	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-001	6770660	2023-05-01	U-1444		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-002	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-002	6770660	2023-05-01	U-1444		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-003	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020913-001	6770660	2023-05-01	U-1444		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020913-002	6770660	2023-05-01	U-1444		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020913-001	6770660	2023-05-01	U-1444		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020913-002	6770660	2023-05-01	U-1444		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-001	6770660	2023-05-01	U-1444		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-002	6770660	2023-05-01	U-1444		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020913-001	6770660	2023-05-01	U-1444		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020913-002	6770660	2023-05-01	U-1444		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020913-001	6770660	2023-05-01	U-1444		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020913-002	6770660	2023-05-01	U-1444		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020913-001	6770660	2023-05-01	U-1444		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020913-002	6770660	2023-05-01	U-1444		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020913-001	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-001	6770660	2023-05-01	U-1444		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-002	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-002	6770660	2023-05-01	U-1444		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-003	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020913-001	6136794	2019-01-29			`b00525d2431f…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIROFIBAN HYDROCHLORIDE	5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6H925F8O5J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737466	Internal RxNorm lookup
1737468	Internal RxNorm lookup
1737471	Internal RxNorm lookup
1737472	Internal RxNorm lookup
1813035	Internal RxNorm lookup
1813037	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
fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3502f65-b30c-cd90-0b5d-36be3bd715c1	Product name	3	20240507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25208-002-01	AGGRASTAT	100 mL in 1 BAG	INJECTION, SOLUTION	100	18
25208-002-01	AGGRASTAT	1 in 1 CARTON	INJECTION, SOLUTION	1	18
25208-002-02	AGGRASTAT	250 mL in 1 CONTAINER	INJECTION, SOLUTION	250	18
25208-002-02	AGGRASTAT	1 in 1 CARTON	INJECTION, SOLUTION	1	18
25208-002-03	AGGRASTAT	100 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	100	18
25208-002-03	AGGRASTAT	1 in 1 CARTON	INJECTION, SOLUTION	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25208-002-01	ML - Milliliter	25208-002	53679249-f6f2-428d-81cf-0bcd86c76d3f	1	2012-07-24
25208-002-02	ML - Milliliter	25208-002	dd10986c-e5cf-4dca-b030-8cc4f8531ac9	1	2012-07-24
25208-002-03	ML - Milliliter	25208-002	4e1f8f93-042f-4ba0-9356-50aef07c750e	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TIROFIBAN HYDROCHLORIDE	ACTIVE INGREDIENT	6H925F8O5J	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8
TIROFIBAN	ACTIVE MOIETY	GGX234SI5H	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25208-002	AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]	18	Current NDC, Legacy NDC, 6 package rows	20241226_fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGGRASTAT	TIROFIBAN	Medicure International Inc	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020913 application number: NDA020913 ndc (product): 25208-002
AGGRASTAT	TIROFIBAN	Medicure International Inc	e850111f-e713-41a2-9c65-21c517cf5511	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020913 application number: NDA020913

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6H925F8O5J	TIROFIBAN HYDROCHLORIDE	150915-40-5	TIROFIBAN HYDROCHLORIDE
GGX234SI5H	TIROFIBAN	144494-65-5	TIROFIBAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737472	AGGRASTAT 12.5 MG in 250 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813037	Aggrastat 3.75 MG in 15 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737468	AGGRASTAT 5 MG in 100 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737471	tirofiban 12.5 MG in 250 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813035	tirofiban 3.75 MG in 15 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737466	tirofiban 5 MG in 100 ML Injection	PSN	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737468	100 ML tirofiban 0.05 MG/ML Injection [Aggrastat]	SBD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813037	15 ML tirofiban 0.25 MG/ML Injection [Aggrastat]	SBD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737472	250 ML tirofiban 0.05 MG/ML Injection [Aggrastat]	SBD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737466	100 ML tirofiban 0.05 MG/ML Injection	SCD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813035	15 ML tirofiban 0.25 MG/ML Injection	SCD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737471	250 ML tirofiban 0.05 MG/ML Injection	SCD	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813037	15 ML Aggrastat 0.25 MG/ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737472	Aggrastat 12.5 MG per 250 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813037	Aggrastat 3.75 MG per 15 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737468	Aggrastat 5 MG per 100 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737468	Aggrastat 50 MCG per 1 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737471	tirofiban (as hydrochloride) 12.5 MG per 250 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737466	tirofiban (as hydrochloride) 5 MG per 100 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737471	tirofiban 12.5 MG per 250 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1813035	tirofiban 3.75 MG per 15 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18
1737466	tirofiban 50 MCG per 1 ML Injection	SY	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25208-002-01	25208000201	1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG	1 bag	2020-12-24	0000-00-00	No	No	Current
25208-002-02	25208000202	1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER	1 container	1998-05-14	0000-00-00	No	No	Current
25208-002-03	25208000203	1 VIAL, GLASS in 1 CARTON (25208-002-03) > 100 mL in 1 VIAL, GLASS		2016-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AGGRASTAT	Medicure International Inc \| Laboratorios Grifols, S.A.	2025-01-01	HUMAN PRESCRIPTION DRUG LABEL	18