Home NDC 42023-622 Bivalirudin
Product NDC 42023-622
11-digit product format 420230622
Labeler code 42023
Product ID 42023-622_e7641caf-d2f1-4a0e-a559-cd14aed68548
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bivalirudin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Endo USA, Inc.
Application NDA211215
Marketing category NDA
Marketing start 2023-06-19
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 N211215-001 ANGIOMAX RTU BIVALIRUDIN 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25
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 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 N211215-001 12472224 2039-05-20 U-3817 Drug product 2025-11-20
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 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211215-001 ANGIOMAX RTU 250MG/50ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 49 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 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211215-001 12472224 2039-05-20 U-3817 Drug product 2025-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211215-001 12472224 2039-05-20 U-3817 Drug product 2025-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211215-001 11992514 2039-05-20 Drug product 2024-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211215-001 11903993 2039-05-20 U-3817 2024-02-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211215-001 11918622 2039-05-20 U-3817 2024-03-06 1e350fbaab3a…
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 1997015 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 42023-622-01 Bivalirudin 1 in 1 CARTON INJECTION, SOLUTION 1 2 42023-622-01 Bivalirudin 1 in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2 42023-622-10 Bivalirudin 1 in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2 42023-622-10 Bivalirudin 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-622 BIVALIRUDIN INJECTION, SOLUTION [ENDO USA, INC.] 2 Current NDC, 4 package rows 20241031_91cf9d00-29e0-4357-a184-f70026c47edb.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 Sample Exclude flag Status 42023-622-01 42023062201 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE 2023-06-19 No No Current 42023-622-10 42023062210 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE 2023-06-19 No No Current