FDA.reportPublic FDA data

NDC 65862-898-28 - Nylia 1/35

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
65862-898
Requested NDC
65862-898-28
Package NDCs from labels
65862-898-28, 65862-898-88, 65862-898-92
Manufacturer
Aurobindo Pharma Limited
Effective date
2022-09-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nylia 1/35 - Aurobindo Pharma LimitedAurobindo Pharma Limited2022-09-07Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-898-28Nylia 1/351 in 1 BLISTER PACKKIT19
65862-898-28Nylia 1/351 in 1 POUCHKIT19
65862-898-88Nylia 1/353 in 1 CARTONKIT39
65862-898-92Nylia 1/351 in 1 POUCHKIT19
65862-898-92Nylia 1/356 in 1 CARTONKIT69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-898NYLIA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 5 package rows20220910_b31bd776-3926-4b77-aa29-f5a8eef611aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-898-88EA - Each65862-8986d680928-5b9e-4b32-a28a-27a2ed264d7812022-01-06

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 9 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSBryant Ranch Prepacked92658d-87e3-4b5a-912f-0b51943da5e32024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited22cfceff-0429-466f-a015-33cfdc505d442024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.71f90c73-63c2-432b-b112-cbdbd26b965c2023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
RhuzdahNORETHINDRONE AND ETHINYL ESTRADIOL TABLETAurobindo Pharma Limiteddea10e78-0e7b-4404-9c3a-ed2447a1788b2023-11-23Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Lo-ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limiteda8c718cc-e235-4710-a9e6-6c58433f30282023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZumandimineDROSPIRENONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited192ad3b0-9ef2-409d-a851-77712202c45a2023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonestLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsdfda3568-b626-4194-b0af-df5d2ea69e3f2023-10-03Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.25f9b952-cc1d-454e-a3ec-834ba1774b6b2023-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.a1f6ea0e-7c14-47c4-83a2-3797bd012eb42023-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.142c4b90-c9ab-45ce-9172-f1ea7d3666862023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.1ba8a8ab-eb09-0807-47d4-6b4055d10d912023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLXiromed, LLC.e1586633-1973-c396-6f4a-4c55cce4b59e2023-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LORYNADROSPIRENONE AND ETHINYL ESTRADIOL TABLETSXiromed, LLC.da872266-d5f2-35df-096e-341f58d934272023-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YasminDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.d7ea6a60-5a56-4f81-b206-9b27b7e588752023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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