Home NDC 68083-145 Tirofiban hydrochloride
Product NDC 68083-145
11-digit product format 680830145
Labeler code 68083
Product ID 68083-145_a206685a-4e0d-40a1-8f39-a4b2f660d7d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tirofiban
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA206888
Marketing category ANDA
Marketing start 2021-04-15
Substance TIROFIBAN HYDROCHLORIDE
Active strength 12.5 mg/250mL
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 RLD / RS 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# 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 12.5 mg/250mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-145-01 Tirofiban hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 7 68083-145-01 Tirofiban hydrochloride 250 mL in 1 CONTAINER INJECTION, SOLUTION 250 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-145 TIROFIBAN HYDROCHLORIDE (TIROFIBAN) INJECTION, SOLUTION [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20210520_fa3ac570-f9f6-474c-a920-bd0cf03045ac.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 Units Marketing start Marketing end Sample Exclude flag Status 68083-145-01 68083014501 1 CONTAINER in 1 CARTON (68083-145-01) / 250 mL in 1 CONTAINER 1 container 2021-04-15 0000-00-00 No No Current