NDC 50102-200-01 - Tulana

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: 50102-200
Requested NDC: 50102-200-01
Package NDCs from labels: 50102-200-01, 50102-200-11, 50102-200-13
Manufacturer: RPK Pharmaceuticals, Inc.
Effective date: 2020-12-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Tulana™ (Norethindrone Tablets USP, 0.35 mg) Rx only	RPK Pharmaceuticals, Inc.	2020-12-24	Human Prescription Drug Label
Tulana - Afaxys Pharma, LLC \| Aurobindo Pharma Limited	Afaxys Pharma, LLC \| Aurobindo Pharma Limited	2020-09-29	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
50102-200-11	EA - Each	50102-200	c993e665-840b-4d99-ba40-a6cf488d4aa2	1	2018-06-11
50102-200-13	EA - Each	50102-200	131ab954-8dbf-41f0-a809-48270d557aa8	1	2018-06-11

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 5 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Emzahh	NORETHINDRONE	Aurobindo Pharma Limited	197d31d3-eec8-49c7-9640-918ff138fea2	2023-04-10	Warnings, Adverse reactions	Exact identifier unii: T18F433X4S
Lyleq	NORETHINDRONE	Afaxys Pharma, LLC	c9f00a3e-c827-4066-bf85-079b3a20f25e	2023-03-27	Warnings, Adverse reactions	Exact identifier application number: ANDA207304 unii: T18F433X4S
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 application number: ANDA207304 unii: T18F433X4S
ec926a59-af01-4ba0-9b12-fbf895e6313c			afd4d5c4-cc99-4679-8790-474644e7c1f9	2020-09-29	Warnings, Adverse reactions	Exact identifier spl id: ec926a59-af01-4ba0-9b12-fbf895e6313c spl set id: afd4d5c4-cc99-4679-8790-474644e7c1f9
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

Reported adverse events (FAERS/openFDA)#

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