FDA.reportPublic FDA data

NDC 0093-7679-01 - Etonogestrel and Ethinyl Estradiol

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
0093-7679
Requested NDC
0093-7679-01
Package NDCs from labels
0093-7679-01, 0093-7679-02
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2022-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Etonogestrel and Ethinyl Estradiol - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2022-09-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7679-01Etonogestrel and Ethinyl Estradiol21 d in 1 POUCHINSERT, EXTENDED RELEASE215
0093-7679-02Etonogestrel and Ethinyl Estradiol3 in 1 CARTONINSERT, EXTENDED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7679ETONOGESTREL AND ETHINYL ESTRADIOL INSERT, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]3Current NDC, Legacy NDC, 2 package rows20221101_a8cc104a-d522-49ad-af54-2f312b829b61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7679-01EA - Each0093-7679573de1bf-837b-4e16-9271-9e2dba3828c712021-02-05
0093-7679-02EA - Each0093-7679e43aff21-f451-4dd8-b92a-15780420057e12021-02-05

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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