AGGRASTAT

Product NDC
25208-001
11-digit product format
252080001
Labeler code
25208
Product ID
25208-001_6fae214d-f37d-49ff-b1bb-266584eb664f
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020912-001AGGRASTATTIROFIBAN HYDROCHLORIDEEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14
N020912-002AGGRASTATTIROFIBAN HYDROCHLORIDEEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020912-001AGGRASTATEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)INJECTABLE / INJECTION1998-05-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020912-002AGGRASTATEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)SOLUTION / INJECTIONRLD, RS2016-08-31bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020912-00167706602023-05-01U-14442013-11-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020912-00267706602023-05-01U-14442016-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020912-00167706602023-05-01U-14442013-11-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020912-00267706602023-05-01U-14442016-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020912-00167706602023-05-01U-14442013-11-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020912-00267706602023-05-01U-14442016-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020912-00161367942019-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020912-00167706602023-05-01U-14442013-11-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020912-00261367942019-01-29U-18982016-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020912-00267706602023-05-01U-14442016-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020912-00167706602023-05-01U-14442013-11-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020912-00267706602023-05-01U-14442016-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020912-00167706602023-05-01U-14442013-11-07782e0a99824c…
2021-12-28 21:50 UTC2021-12N020912-00267706602023-05-01U-14442016-09-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020912-00167706602023-05-01U-14442013-11-0787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020912-00267706602023-05-01U-14442016-09-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N020912-00167706602023-05-01U-14442013-11-075aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020912-00267706602023-05-01U-14442016-09-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020912-00167706602023-05-01U-14442013-11-078869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020912-00267706602023-05-01U-14442016-09-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020912-00167706602023-05-01U-14442013-11-07c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020912-00267706602023-05-01U-14442016-09-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020912-00161367942019-01-293f01610625f2…
2019-12-14 00:12 UTC2019-12N020912-00167706602023-05-01U-14442013-11-073f01610625f2…
2019-12-14 00:12 UTC2019-12N020912-00261367942019-01-29U-18982016-09-293f01610625f2…
2019-12-14 00:12 UTC2019-12N020912-00267706602023-05-01U-14442016-09-293f01610625f2…
2019-09-15 20:21 UTC2019-09N020912-00161367942019-01-29b00525d2431f…
2019-09-15 20:21 UTC2019-09N020912-00167706602023-05-01U-14442013-11-07b00525d2431f…
2019-09-15 20:21 UTC2019-09N020912-00261367942019-01-29U-18982016-09-29b00525d2431f…
2019-09-15 20:21 UTC2019-09N020912-00267706602023-05-01U-14442016-09-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N020912-00161367942019-01-29ea99ee380514…
2019-07-19 19:46 UTC2019-07N020912-00167706602023-05-01U-14442013-11-07ea99ee380514…
2019-07-19 19:46 UTC2019-07N020912-00261367942019-01-29U-18982016-09-29ea99ee380514…
2019-07-19 19:46 UTC2019-07N020912-00267706602023-05-01U-14442016-09-29ea99ee380514…
2023-12-20 04:57 UTC2023-12N020912-00167706602023-05-01U-14442013-11-07ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N020912-00267706602023-05-01U-14442016-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020912-00167706602023-05-01U-14442013-11-07a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020912-00267706602023-05-01U-14442016-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020912-00167706602023-05-01U-14442013-11-079b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020912-00267706602023-05-01U-14442016-09-299b2671bbb829…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIROFIBAN HYDROCHLORIDE3.75 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6H925F8O5JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737466Internal RxNorm lookup
1737468Internal RxNorm lookup
1737471Internal RxNorm lookup
1737472Internal RxNorm lookup
1813035Internal RxNorm lookup
1813037Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe0ced75-ccbf-4d2e-bd0d-b57e60ab913fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3502f65-b30c-cd90-0b5d-36be3bd715c1Product name320240507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25208-001-04AGGRASTAT1 in 1 CARTONINJECTION, SOLUTION118
25208-001-04AGGRASTAT15 mL in 1 VIAL, GLASSINJECTION, SOLUTION1518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25208-001-04ML - Milliliter25208-0010ea44884-a0a7-4895-b42e-c8f210c6779912016-11-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25208-001AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]18Current NDC, Legacy NDC, 2 package rows20241226_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGGRASTATTIROFIBANMedicure International Incfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f2025-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020912
application number: NDA020912
ndc (product): 25208-001
AGGRASTATTIROFIBANMedicure International Ince850111f-e713-41a2-9c65-21c517cf55112025-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020912
application number: NDA020912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737472AGGRASTAT 12.5 MG in 250 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1813037Aggrastat 3.75 MG in 15 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737468AGGRASTAT 5 MG in 100 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737471tirofiban 12.5 MG in 250 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1813035tirofiban 3.75 MG in 15 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737466tirofiban 5 MG in 100 ML InjectionPSNfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737468100 ML tirofiban 0.05 MG/ML Injection [Aggrastat]SBDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
181303715 ML tirofiban 0.25 MG/ML Injection [Aggrastat]SBDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737472250 ML tirofiban 0.05 MG/ML Injection [Aggrastat]SBDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737466100 ML tirofiban 0.05 MG/ML InjectionSCDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
181303515 ML tirofiban 0.25 MG/ML InjectionSCDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737471250 ML tirofiban 0.05 MG/ML InjectionSCDfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
181303715 ML Aggrastat 0.25 MG/ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737472Aggrastat 12.5 MG per 250 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1813037Aggrastat 3.75 MG per 15 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737468Aggrastat 5 MG per 100 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737468Aggrastat 50 MCG per 1 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737471tirofiban (as hydrochloride) 12.5 MG per 250 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737466tirofiban (as hydrochloride) 5 MG per 100 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737471tirofiban 12.5 MG per 250 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1813035tirofiban 3.75 MG per 15 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18
1737466tirofiban 50 MCG per 1 ML InjectionSYfe0ced75-ccbf-4d2e-bd0d-b57e60ab913f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25208-001-04252080001041 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS2016-10-150000-00-00NoNoCurrent