Angiomax

Product NDC: 65293-001
Requested package NDC: 65293-001-01
11-digit product format: 652930001
Labeler code: 65293
Product ID: 65293-001_8f7c7c4a-6699-40ca-b308-b95ad5cea33a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bivalirudin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: The Medicines Company
Application: NDA020873
Marketing category: NDA
Marketing start: 2000-12-15
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

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	65293-001	65293-001-01	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
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	Coverage / status
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020873-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020873-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020873-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020873-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020873-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020873-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020873-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020873-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020873-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020873-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020873-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020873-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020873-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020873-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020873-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020873-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020873-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020873-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020873-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020873-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020873-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020873-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020873-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020873-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020873-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020873-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020873-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020873-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020873-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020873-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020873-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020873-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020873-001	AP	1	`cb3db0bc1861…`

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	Coverage / status	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65293-001-01	EA - Each	65293-001	ca4ab667-52d7-4e17-8524-3ac5dee7f34f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BIVALIRUDIN	ACTIVE INGREDIENT	TN9BEX005G	ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	16
BIVALIRUDIN	ACTIVE MOIETY	TN9BEX005G	ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	16
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	16
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ANGIOMAX (BIVALIRUDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THE MEDICINES COMPANY]	16

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	Civica, Inc.	19a4afc5-151d-4d3c-bfef-48aa8797d695	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020873 application number: NDA020873
bivalirudin	BIVALIRUDIN	Sandoz Inc	ce56f806-7845-429d-a1ce-c2dbf79b22eb	2019-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020873 application number: NDA020873

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	Marketing start	Marketing end	Sample	Exclude flag	Status
65293-001-01	65293000101	10 VIAL, SINGLE-USE in 1 CARTON (65293-001-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE	2000-12-15	0000-00-00	No	No	Current