Home NDC 0338-9576 Bivalirudin in 0.9% Sodium Chloride
Product NDC 0338-9576
11-digit product format 003389576
Labeler code 0338
Product ID 0338-9576_68a6b49d-9eb8-4d19-9b4a-41f17572b438
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bivalirudin in 0.9% Sodium Chloride Injection
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA208374
Marketing category NDA
Marketing start 2017-12-21
Marketing end 0000-00-00
Substance BIVALIRUDIN
Active strength 500 mg/100mL
Pharmacologic classes Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0338-9576-12 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0338-9576-12 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0338-9576-12 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0338-9576-12 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0338-9576-12 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0338-9576-12 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0338-9576-12 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0338-9576-12 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0338-9576-12 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0338-9576-12 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0338-9576-12 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0338-9576-12 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0338-9576-12 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE BIVALIRUDIN 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE BIVALIRUDIN 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208374-001 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208374-002 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 500MG/100ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 782e0a99824c…
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-9576-12 00338957612 12 BAG in 1 CARTON (0338-9576-12) > 100 mL in 1 BAG 12 bag 2017-12-21 0000-00-00 No No Current