Home NDC 14789-102-10 Tirofiban Hydrochloride
Product NDC 14789-102
Requested package NDC 14789-102-10
11-digit product format 147890102
Labeler code 14789
Product ID 14789-102_2dfa5385-2e91-c26a-e063-6394a90a37aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tirofiban Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Nexus Pharmaceuticals LLC
Application ANDA213947
Marketing category ANDA
Marketing start 2023-09-25
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 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 A213947-001 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 A213947-002 TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24
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 · 47 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 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213947-001 TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-02-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213947-002 TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP 2023-07-24 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 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 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 · 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 14789-102-02 Tirofiban Hydrochloride 250 mL in 1 BAG INJECTION 250 10 14789-102-02 Tirofiban Hydrochloride 1 in 1 CARTON INJECTION 1 10 14789-102-10 Tirofiban Hydrochloride 2 in 1 CARTON INJECTION 2 10 14789-102-10 Tirofiban Hydrochloride 250 mL in 1 BAG INJECTION 250 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14789-102 TIROFIBAN HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC] 10 Current NDC, 4 package rows 20250221_7731e46a-2121-441b-b090-12dcefe240f0.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 14789-102-10 14789010210 2 BAG in 1 CARTON (14789-102-10) / 250 mL in 1 BAG 2 bag 2024-02-10 No No Current