FDA.reportPublic FDA data

NDC 68180-500 - Vyfemla

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
68180-500
Package NDCs from labels
68180-500-74
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2025-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vyfemla - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-11-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-500VYFEMLA ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]5Unmatched20241228_175ce5c4-d332-4c97-a0b8-10821dc813ef.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 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 749736
rxcui: 238015
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
NextstellisDROSPIRENONE AND ESTETROLMayne Pharmac5270073-d083-4109-ae4b-156986175e0a2023-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-VyLibra LoNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCbd51a08e-cd45-4315-9bca-41794450ef162023-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP9c4fac8e-8744-4378-80af-7887de955a512023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EmzahhNORETHINDRONEAurobindo Pharma Limited197d31d3-eec8-49c7-9640-918ff138fea22023-04-10Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Levonorgetsrel and Ethinyl EstradiolLEVONORGETSREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.b04e1404-6eee-48f3-a51e-66de3fc95b602023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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