FDA.reportPublic FDA data

NDC 68180-495 - 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
68180-495
Package NDCs from labels
68180-495-74
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-495-74Vyfemla21 in 1 BLISTER PACKTABLET210.4 mg6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-495VYFEMLA ( 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 15 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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.