Home NDC 52958-034 Bivalirudin
Product NDC 52958-034
11-digit product format 529580034
Labeler code 52958
Product ID 52958-034_463422b6-e6d2-4319-a95e-aed834c2c844
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bivalirudin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Application ANDA210031
Marketing category ANDA
Marketing start 2019-10-23
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 A210031-001 BIVALIRUDIN BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210031-001 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 2026-02-19 14:30 UTC 2026-02 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210031-001 BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP 2019-10-23 a50c72e98297…
Observed Orange Book normalized TE history# 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 52958-034-01 Bivalirudin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 5 52958-034-01 Bivalirudin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52958-034 BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] 5 Current NDC, Legacy NDC, 2 package rows 20241224_61de12ff-e280-4bab-9804-43869ec45fa7.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 52958-034-01 52958003401 10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2019-10-23 0000-00-00 No No Current