NDC 0093-8073-28 - Kelnor 1/50

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
0093-8073
Requested NDC
0093-8073-28
Package NDCs from labels
0093-8073-28, 0093-8073-16
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2021-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kelnor 1/50 - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2021-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8073KELNOR 1/50 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]4Legacy NDC20211218_ed075d59-4b6f-467c-bcb1-4dda272d27aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8073-16EA - Each0093-8073a8ac7c04-9304-4ea7-abaf-4ee9aba9899a12018-03-08
0093-8073-28EA - Each0093-8073b52b7bb5-cf2e-45f5-84a3-0422be1e7b9912018-04-19

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 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ba56e2eb-7101-48d4-9a87-95e4340079b5ed075d59-4b6f-467c-bcb1-4dda272d27aa2021-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: ba56e2eb-7101-48d4-9a87-95e4340079b5
spl set id: ed075d59-4b6f-467c-bcb1-4dda272d27aa
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.