Home NDC 25208-901 AGGRASTAT
Product NDC 25208-901
11-digit product format 252080901
Labeler code 25208
Product ID 25208-901_d7b2e8c6-afd1-4e94-b780-ed2fc439e3f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TIROFIBAN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medicure International Inc
Application NDA020912
Marketing category NDA
Marketing start 2016-10-15
Substance TIROFIBAN HYDROCHLORIDE
Active strength 3.75 mg/15mL
Pharmacologic classes Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
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 N020912-001 AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 N020912-002 AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020912-001 AGGRASTAT EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020912-002 AGGRASTAT EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION / INJECTION RLD, RS 2016-08-31 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 2 · 56 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020912-001 6136794 2019-01-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020912-002 6136794 2019-01-29 U-1898 2016-09-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020912-001 6136794 2019-01-29 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020912-002 6136794 2019-01-29 U-1898 2016-09-29 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020912-001 6136794 2019-01-29 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020912-002 6136794 2019-01-29 U-1898 2016-09-29 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020912-001 6136794 2019-01-29 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020912-002 6136794 2019-01-29 U-1898 2016-09-29 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 ea99ee380514…2023-12-20 04:57 UTC 2023-12 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020912-001 6770660 2023-05-01 U-1444 2013-11-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020912-002 6770660 2023-05-01 U-1444 2016-09-29 9b2671bbb829…
Additional Listing Data#
Finished product Yes
Brand name base AGGRASTAT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIROFIBAN HYDROCHLORIDE 3.75 mg/15mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25208-901-04 AGGRASTAT 1 in 1 CARTON INJECTION, SOLUTION 1 3 25208-901-04 AGGRASTAT 15 mL in 1 VIAL, GLASS INJECTION, SOLUTION 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25208-901 AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC] 3 Current NDC, 2 package rows 20241226_e850111f-e713-41a2-9c65-21c517cf5511.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 25208-901-04 25208090104 1 VIAL, GLASS in 1 CARTON (25208-901-04) / 15 mL in 1 VIAL, GLASS 2016-10-15 No No Current