Home NDC 55150-429 Tirofiban
Product NDC 55150-429
11-digit product format 551500429
Labeler code 55150
Product ID 55150-429_1751523a-e22e-4faf-bdb1-c850afe2fd36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tirofiban
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA216379
Marketing category ANDA
Marketing start 2023-05-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216379-001 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 A216379-002 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 48 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 2026-09-14 22:38:34 2026-08 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216379-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216379-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-05-01 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tirofiban
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737466 Internal RxNorm lookup 1737471 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 55150-429-01 Tirofiban 1 in 1 POUCH INJECTION, SOLUTION 1 2 55150-429-01 Tirofiban 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-429 TIROFIBAN INJECTION, SOLUTION [EUGIA US LLC] 2 Current NDC, 2 package rows 20230714_d554acff-22e9-4f28-b826-ee1b91daa2df.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55150-429-01 55150042901 1 POUCH in 1 CARTON (55150-429-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 1 pouch 2023-05-01 No No Current