bivalirudin

Product NDC: 72572-035
Requested package NDC: 72572-035-10
11-digit product format: 725720035
Labeler code: 72572
Product ID: 72572-035_53431803-dc0b-42dc-8766-e17c3dbdf4ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bivalirudin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Civica, Inc.
Application: NDA020873
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-12-21
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
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.

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
2026-08-01 22:54:32	2026-06	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N020873-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-08-01 22:54:32	2026-06	N020873-001	7582727	2028-07-27	Drug product	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020873-001	7598343	2028-07-27	Drug product	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 72572-035-10 ndc (product): 72572-035 ndc11 (package): 72572003510
bivalirudin	BIVALIRUDIN	Sandoz Inc	ce56f806-7845-429d-a1ce-c2dbf79b22eb	2019-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020873 application number: NDA020873

Additional Listing Data#

Finished product: Yes
Brand name base: bivalirudin
Listing expiration: 2026-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19a4afc5-151d-4d3c-bfef-48aa8797d695	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1c25cd48-e81c-4683-ac07-71f9a642e2bf	Product name	9	20211217
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
325b79a5-b460-45d7-abfc-c4784f5b0531	Product name	1	20191120
c3370853-5a7f-4c73-a273-26ef0162f2f3	Product name	1	20180308
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72572-035-10	2025-09-11	C162847	48780-1	3b156c62-26ee-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000
72572-035-10	2025-07-29	C162847	48780-1	3b156c62-26ee-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72572-035-01	bivalirudin	1 in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	1		2
72572-035-10	bivalirudin	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-035-01	EA - Each	72572-035	7c2971d0-3f34-4732-8722-d0be4aef66ac	1	2021-01-08
72572-035-10	EA - Each	72572-035	ac27ca37-d27c-4784-8180-056baa0d016d	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72572-035	BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20201221_19a4afc5-151d-4d3c-bfef-48aa8797d695.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308769	bivalirudin 250 MG Injection	PSN	19a4afc5-151d-4d3c-bfef-48aa8797d695	2
308769	bivalirudin 250 MG Injection	SCD	19a4afc5-151d-4d3c-bfef-48aa8797d695	2
308769	bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML Injection	SY	19a4afc5-151d-4d3c-bfef-48aa8797d695	2
308769	bivalirudin 50 MG/ML Injection	SY	19a4afc5-151d-4d3c-bfef-48aa8797d695	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-035-10	72572003510	10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)	2020-12-21	0000-00-00	No	No	Current