Bivalirudin

Product NDC: 70860-403
Requested package NDC: 70860-403-51
11-digit product format: 708600403
Labeler code: 70860
Product ID: 70860-403_e670c25e-1572-4492-a6b5-4f42ba4b389a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bivalirudin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: NDA211215
Marketing category: NDA
Marketing start: 2020-03-01
Marketing end: 0000-00-00
Substance: BIVALIRUDIN
Active strength: 5 mg/mL
Pharmacologic classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-403	70860-403-51	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-403-51	2024-03-02	C162847	48780-1	1030e365-5946-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BIVALIRUDIN RTU INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN RTU INJECTION. BIVALIRUDIN RTU (bivalirudin) injection, for intravenous use Initial U.S. Approval: 2000
70860-403-51	2024-01-30	C162847	48780-1	1030e365-5946-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BIVALIRUDIN RTU INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN RTU INJECTION. BIVALIRUDIN RTU (bivalirudin) injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-403-50	ML - Milliliter	70860-403	6b458038-5c20-427d-9e96-893b2c7c3547	1	2020-03-10
70860-403-51	ML - Milliliter	70860-403	311de9e9-6aaf-4720-aadc-2eeec21a9f06	1	2020-03-10

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bivalirudin	BIVALIRUDIN	MAIA Pharmaceuticals, Inc.	c727199d-f4cd-4658-8fdf-568590beface	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211215 application number: NDA211215
Bivalirudin	BIVALIRUDIN	Par Health USA, LLC	91cf9d00-29e0-4357-a184-f70026c47edb	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211215 application number: NDA211215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TN9BEX005G	BIVALIRUDIN	128270-60-0	BIVALIRUDIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-403-51	70860040351	10 CARTON in 1 CARTON (70860-403-51) > 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-403-50) > 50 mL in 1 VIAL, SINGLE-DOSE	10 carton	2020-03-01	0000-00-00	No	No	Current