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 10 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Norethindrone and ethinyl estradiolNORETHINDRONE AND ETHINYL ESTRADIOLNaari Pte Limited9bd9119e-a874-41e2-ac58-b7f0d155d2fb2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLNaari Pte. Limitedd96f0dd8-4eb9-42f7-ab5e-b5515dcf73d62024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiol and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNaari Pte. Limitedf8961550-d103-8ee6-e053-6294a90a75712024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLDr. Reddy's Laboratories Inc.1ca12bf6-9583-4578-8411-51ad02a405ec2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
KarivaDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.7b11e11f-6977-4109-b9bd-a066e5d1278a2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions4d888008-cc14-4291-b384-0d482f48eb082024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCf59acc3e-21d9-4fa3-ad52-d77225739e1a2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VolneaDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack0e65209d-329a-4d31-8afb-24348dc8d7e72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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