Tirofiban Hydrochloride

Product NDC: 25021-417
11-digit product format: 250210417
Labeler code: 25021
Product ID: 25021-417_42fc0d8a-6595-491f-aedb-6451129d239d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tirofiban Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA206888
Marketing category: ANDA
Marketing start: 2024-11-15
Substance: TIROFIBAN HYDROCHLORIDE
Active strength: 50 ug/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206888-001	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2021-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206888-001	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.

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	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206888-001	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-08	`a50c72e98297…`

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	A206888-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206888-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206888-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206888-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206888-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206888-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206888-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206888-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206888-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206888-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206888-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206888-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206888-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206888-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206888-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206888-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206888-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206888-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206888-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206888-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206888-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206888-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206888-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206888-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206888-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206888-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206888-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206888-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206888-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206888-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206888-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206888-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206888-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206888-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIROFIBAN HYDROCHLORIDE	50 ug/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737471	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
13ea7fb8-4b01-4286-9464-26c0b624bc3b	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25021-417-84	Tirofiban Hydrochloride	250 mL in 1 BAG	INJECTION, SOLUTION	250		1
25021-417-84	Tirofiban Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-417-84	ML - Milliliter	25021-417	a88f9894-c78a-44f3-8f3d-6b6dd24ff851	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-417	TIROFIBAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	1	Current NDC, 2 package rows	20241116_13ea7fb8-4b01-4286-9464-26c0b624bc3b.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
Tirofiban Hydrochloride	TIROFIBAN HYDROCHLORIDE	Sagent Pharmaceuticals	13ea7fb8-4b01-4286-9464-26c0b624bc3b	2024-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206888 application number: ANDA206888 ndc (product): 25021-417
Tirofiban hydrochloride	TIROFIBAN	Gland Pharma Limited	fa3ac570-f9f6-474c-a920-bd0cf03045ac	2021-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206888 application number: ANDA206888

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737471	tirofiban 12.5 MG in 250 ML Injection	PSN	13ea7fb8-4b01-4286-9464-26c0b624bc3b	1
1737471	250 ML tirofiban 0.05 MG/ML Injection	SCD	13ea7fb8-4b01-4286-9464-26c0b624bc3b	1
1737471	tirofiban (as hydrochloride) 12.5 MG per 250 ML Injection	SY	13ea7fb8-4b01-4286-9464-26c0b624bc3b	1
1737471	tirofiban 12.5 MG per 250 ML Injection	SY	13ea7fb8-4b01-4286-9464-26c0b624bc3b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25021-417-84	25021041784	1 BAG in 1 CARTON (25021-417-84) / 250 mL in 1 BAG	1 bag	2024-11-15	No	No	Current