NDC 51862-100-01 - Errin

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: 51862-100
Requested NDC: 51862-100-01
Package NDCs from labels: 51862-100-01, 51862-100-06
Manufacturer: Mayne Pharma Inc. | Teva Women's Health, Inc.
Effective date: 2018-10-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Errin ® (norethindrone tablets USP 0.35 mg)	Mayne Pharma Inc. \| Teva Women's Health, Inc.	2018-10-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-100-01	EA - Each	51862-100	8bf50645-c5e8-4421-959e-00ea2c9f56ea	1	2017-03-06
51862-100-06	EA - Each	51862-100	744b31fc-17a0-46ef-941d-73ec3005d724	1	2017-03-06

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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortrel 28 Day	NORETHINDRONE AND ETHINYL ESTRADIOL	Teva Pharmaceuticals USA, Inc.	140c50d6-c931-423a-9aa0-526eae7ab93c	2021-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: T18F433X4S
Incassia	NORETHINDRONE	Aurobindo Pharma Limited	0b87cef0-610c-469d-92ba-4007f4bc3878	2021-09-14	Warnings, Adverse reactions	Exact identifier unii: T18F433X4S
Norethindrone	NORETHINDRONE	Proficient Rx LP	fb84b86e-5f1f-4c17-8b69-ff695c5faf55	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: T18F433X4S
NORETHINDRONE	NORETHINDRONE	Mylan Pharmaceuticals Inc.	af851d82-b30f-463b-9dba-0437225dc1ee	2018-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: T18F433X4S
05c452d3-dfac-4036-8c2d-536a03ed99a0			b98c5463-7f38-440d-928c-c0fa722b28ae	2018-10-17	Warnings, Adverse reactions	Exact identifier spl id: 05c452d3-dfac-4036-8c2d-536a03ed99a0 spl set id: b98c5463-7f38-440d-928c-c0fa722b28ae

Reported adverse events (FAERS/openFDA)#

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