Home NDC 0781-3158 bivalirudin
Product NDC 0781-3158
11-digit product format 007813158
Labeler code 0781
Product ID 0781-3158_6260b3ba-2bf2-4196-a9f6-4e7e159be5a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bivalirudin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application NDA020873
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-06-15
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 0781-3158-95 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 0781-3158-95 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 N020873-001 ANGIOMAX BIVALIRUDIN 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020873-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N020873-001 7582727 2028-07-27 Drug product N020873-001 7598343 2028-07-27 Drug product N020873-001 7582727*PED 2029-01-27 Pediatric extension N020873-001 7598343*PED 2029-01-27 Pediatric extension
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 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020873-001 ANGIOMAX 250MG/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2000-12-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020873-001 7582727 2028-07-27 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020873-001 7598343 2028-07-27 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020873-001 7582727*PED 2029-01-27 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020873-001 7598343*PED 2029-01-27 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020873-001 7582727 2028-07-27 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020873-001 7598343 2028-07-27 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020873-001 7582727*PED 2029-01-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020873-001 7598343*PED 2029-01-27 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020873-001 7582727 2028-07-27 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020873-001 7598343 2028-07-27 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020873-001 7582727*PED 2029-01-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020873-001 7598343*PED 2029-01-27 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020873-001 7582727 2028-07-27 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020873-001 7598343 2028-07-27 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020873-001 7582727*PED 2029-01-27 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020873-001 7598343*PED 2029-01-27 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020873-001 7582727 2028-07-27 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020873-001 7598343 2028-07-27 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020873-001 7582727*PED 2029-01-27 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020873-001 7598343*PED 2029-01-27 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020873-001 7582727 2028-07-27 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020873-001 7598343 2028-07-27 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020873-001 7582727*PED 2029-01-27 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020873-001 7598343*PED 2029-01-27 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020873-001 7582727 2028-07-27 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020873-001 7598343 2028-07-27 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020873-001 7582727*PED 2029-01-27 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020873-001 7598343*PED 2029-01-27 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020873-001 7582727 2028-07-27 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020873-001 7598343 2028-07-27 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020873-001 7582727*PED 2029-01-27 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020873-001 7598343*PED 2029-01-27 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020873-001 7582727 2028-07-27 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020873-001 7598343 2028-07-27 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020873-001 7582727*PED 2029-01-27 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020873-001 7598343*PED 2029-01-27 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020873-001 7582727 2028-07-27 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020873-001 7598343 2028-07-27 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020873-001 7582727*PED 2029-01-27 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020873-001 7598343*PED 2029-01-27 Pediatric extension d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base bivalirudin
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-3158-94 bivalirudin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 4 0781-3158-95 bivalirudin 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BIVALIRUDIN ACTIVE INGREDIENT TN9BEX005G BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] 1 BIVALIRUDIN ACTIVE MOIETY TN9BEX005G BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3158 BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 4 Legacy NDC, 2 package rows 20191003_ce56f806-7845-429d-a1ce-c2dbf79b22eb.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 0781-3158-94 00781315894 1 in 1 VIAL, SINGLE-USE Historical 0781-3158-95 00781315895 10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94) 2015-06-15 0000-00-00 No No Current