NDC 72572-035-01 - bivalirudin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 72572-035
Requested NDC: 72572-035-01
Package NDCs from labels: 72572-035-01, 72572-035-10
Manufacturer: Civica, Inc.
Effective date: 2025-09-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
bivalirudin - Civica, Inc.	Civica, Inc.	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
bivalirudin	BIVALIRUDIN	Slate Run Pharmaceuticals, LLC	5d9a45c6-e234-4d56-9132-5e24e65852e6	2021-06-09	Warnings, Adverse reactions	Exact identifier rxcui: 308769 unii: TN9BEX005G
BIVALIRUDIN	BIVALIRUDIN	Meitheal Pharmaceuticals Inc.	4119b710-ef30-4e3e-b99a-38e42b4b3fca	2021-06-08	Warnings, Adverse reactions	Exact identifier rxcui: 308769 unii: TN9BEX005G
bivalirudin	BIVALIRUDIN	Sandoz Inc	ce56f806-7845-429d-a1ce-c2dbf79b22eb	2019-09-30	Warnings, Adverse reactions	Exact identifier application number: NDA020873 rxcui: 308769 unii: TN9BEX005G
Bivalirudin	BIVALIRUDIN	Dr. Reddy's Laboratories Limited	19beb2ae-6064-3c24-fe50-0cee86896979	2019-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 308769 unii: TN9BEX005G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.