FDA.reportPublic FDA data

NDC 65862-899-28 - Cyonanz

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
65862-899
Requested NDC
65862-899-28
Package NDCs from labels
65862-899-28, 65862-899-88, 65862-899-92
Manufacturer
Aurobindo Pharma Limited
Effective date
2021-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyonanz - Aurobindo Pharma LimitedAurobindo Pharma Limited2021-12-03Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-899-28Cyonanz1 in 1 POUCHKIT16
65862-899-28Cyonanz1 in 1 BLISTER PACKKIT16
65862-899-88Cyonanz3 in 1 CARTONKIT36
65862-899-92Cyonanz1 in 1 POUCHKIT16
65862-899-92Cyonanz6 in 1 CARTONKIT66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-899CYONANZ (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 5 package rows20211213_2bd1b72e-fba5-4275-a02a-ed08a5434a92.zip

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 12 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.563297dc-f27b-46e3-83de-bade17473d622021-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LessinaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a5fd1b3a-019c-4871-95b3-a45bbbd46f822021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.47263647-a9ac-40e4-83c0-d6500fa458cd2021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a9e08f9b-9862-4c2c-8302-53dc82d851262021-12-15Warnings, Adverse reactionsExact identifier
rxcui: 748797
CyonanzNORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited2bd1b72e-fba5-4275-a02a-ed08a5434a922021-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207055
ndc (package): 65862-899-92
ndc (package): 65862-899-88
ndc (package): 65862-899-28
ndc (product): 65862-899
ndc11 (package): 65862089928
rxcui: 748797
rxcui: 749879
rxcui: 310463
rxcui: 1856398
spl id: e128a04a-71a7-402c-9afd-375104504b92
spl set id: 2bd1b72e-fba5-4275-a02a-ed08a5434a92
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.992dcc56-90ab-4691-8114-16d47a8b99822021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 310463
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749879
rxcui: 310463
unii: T18F433X4S
unii: 423D2T571U
IncassiaNORETHINDRONEAurobindo Pharma Limited0b87cef0-610c-469d-92ba-4007f4bc38782021-09-14Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Estradiol Valerate and Estradiol Valerate/DienogestESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTSandoz Inc0c3ac139-af85-4c70-ad3d-981e57d86f022020-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPc1fc22e5-e02d-4dda-a9ac-c592e922c4672020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd19ff955-1778-43c7-a111-476d740dc9d92019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NorethindroneNORETHINDRONEProficient Rx LPfb84b86e-5f1f-4c17-8b69-ff695c5faf552019-11-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
NORETHINDRONENORETHINDRONEMylan Pharmaceuticals Inc.af851d82-b30f-463b-9dba-0437225dc1ee2018-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Tri FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC46bbdf70-2b80-4359-a19b-d94ff99eac982016-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC59bce25b-ee2c-4f06-afff-e5141d0636022016-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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