Home NDC 70860-402 Bivalirudin
Product NDC 70860-402
11-digit product format 708600402
Labeler code 70860
Product ID 70860-402_556410e5-3149-4de4-8bea-aa90b7df437d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bivalirudin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA210031
Marketing category ANDA
Marketing start 2019-11-30
Marketing end 0000-00-00
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 2020-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70860-402-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70860-402-10 f5e01cc5f278…a2eaf40c39c3…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-402 BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 2 Legacy NDC 20240304_65b6f8fc-ae1f-45d6-9b7a-8bb3cc279f8f.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70860-402-10 70860040210 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-402-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70860-402-41) 2019-11-30 0000-00-00 No No Current