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 11 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.96a73786-22b1-457e-be73-80b699996d402022-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Velivet Triphasic RegimenDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a3ce5125-62ba-4983-93f0-91f2542716052022-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedd9d2d0a1-b336-40ee-b4cc-b3d876ca91b92022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 1/35NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb31bd776-3926-4b77-aa29-f5a8eef611aa2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LP5b684f8f-9610-4449-a213-f70bb4a04b8b2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 310463
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited867c5630-51be-4469-bf79-6a5cd4302cfa2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 310463
IntrovaleLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.f5bc2427-3a18-e3e6-a058-210688e9c4462022-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4e1927bd-378d-45dc-8b18-3dd57ccd2cb62022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Reclipsen 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a1e00bc6-7487-4057-9dcc-d0e2327d1d122022-01-04Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cb2021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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