NDC 00591-405-01

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: 00591-405
Requested NDC: 00591-405-01
Package NDCs from labels: 00591-405-01
Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-11	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
00591-405-01	EA - Each	00591-405	bceef6e1-d0da-41cb-b936-e4eb8692f48d	1	2013-02-11
00591-405-05	EA - Each	00591-405	08c2701a-f205-423f-9645-9d3efe4d3e4e	1	2013-02-11

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 12 of 12 · 222 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	5eea66bd-589a-45f8-ba2c-dea66a939d59	2019-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: E7199S1YWR
Lisinopril	LISINOPRIL	Actavis Pharma, Inc.	43e2c8d1-3704-4323-bcaf-f582572b81f7	2017-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA076059 ndc (package): 0591-0405-01 ndc (product): 0591-0405 ndc11 (package): 00591040501 rxcui: 314077 rxcui: 197884 rxcui: 205326 rxcui: 314076 rxcui: 311353 rxcui: 311354 spl id: 01764c1d-aebe-4a46-920c-4b5f8cca8acb spl set id: 43e2c8d1-3704-4323-bcaf-f582572b81f7 unii: E7199S1YWR

Reported adverse events (FAERS/openFDA)#

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