Home NDC 63323-562 Bivalirudin
Product NDC 63323-562
11-digit product format 633230562
Labeler code 63323
Product ID 63323-562_2f51e657-4541-4458-8020-5063efc51eb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bivalirudin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090189
Marketing category ANDA
Marketing start 2016-10-28
Substance BIVALIRUDIN
Active strength 250 mg/1
Pharmacologic classes Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
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 1 .
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 A090189-001 BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090189-001 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.
Product history page 1 of 2 · 41 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 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090189-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2016-10-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bivalirudin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIVALIRUDIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TN9BEX005G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308769 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 63323-562-10 Bivalirudin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 5 63323-562-10 Bivalirudin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 5 63323-562-15 Bivalirudin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 4 63323-562-41 Bivalirudin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-562 BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 4 Current NDC, Legacy NDC, 2 package rows 20210123_af943fa0-ab0f-4b62-9ff0-54ee24cdb772.zip 63323-562 BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 3 Current NDC, Legacy NDC, 2 package rows 20210616_50975be1-6d1f-497c-b989-1825a0fae1a7.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 Marketing start Marketing end Sample Exclude flag Status 63323-562-10 63323056210 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2016-10-28 0000-00-00 No No Current 63323-562-15 63323056215 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41) 2017-10-30 0000-00-00 No No Current 63323-562-41 63323056241 1 in 1 VIAL, SINGLE-USE Historical