NDC 42291-850-18

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: 42291-850
Requested NDC: 42291-850-18
Package NDCs from labels: 42291-850-18
Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
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	2012-07-24	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
42291-850-10	EA - Each	42291-850	656b1acd-c306-4490-8b4c-72f62fc4afff	1	2014-09-03
42291-850-18	EA - Each	42291-850	dd39d467-cd8c-4b1a-84d3-04dec96deb26	1	2012-07-24

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Major Pharmaceuticals	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	2025-01-09	Warnings, Adverse reactions	Exact identifier application number: ANDA075517
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	9d7f26d5-d8a9-4610-8d78-80ca3d442a79	2024-12-19	Adverse reactions	Exact identifier application number: ANDA075517
Ursodiol	URSODIOL	Bryant Ranch Prepack	011ede7f-bb4d-45f7-8041-9feb4aa2ba7d	2023-12-07	Adverse reactions	Exact identifier application number: ANDA075517
Ursodiol	URSODIOL	Epic Pharma, LLC	e47b49ca-bde9-448a-bf61-f943c2aa5b8e	2023-08-10	Warnings, Adverse reactions	Exact identifier application number: ANDA075517
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	4a161c84-141c-4741-8d69-31a6f3dfd18d	2021-10-01	Adverse reactions	Exact identifier application number: ANDA075517

Reported adverse events (FAERS/openFDA)#

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