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 13 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LyleqNORETHINDRONEAfaxys Pharma, LLCc9f00a3e-c827-4066-bf85-079b3a20f25e2023-03-27Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepackc607816d-0da9-4960-9723-69f28aa3f2f22023-03-02Boxed warningExact identifier
rxcui: 748797
VolneaDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.d7f3a118-4a1a-786e-c1db-01a0c2f2189d2023-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions51e4270a-1b91-4ff8-9a50-ffe49204b6b42023-02-21Boxed warning, WarningsExact identifier
rxcui: 748797
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.7dbc4cdf-4ce2-5c66-343f-df381f56692a2023-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALTAVERALEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.4701e72b-6378-a771-fb88-1b703031a8bc2023-02-10Boxed warningExact identifier
rxcui: 748797
Kelnor 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLA-S Medication Solutionscfa297a6-1cc7-4751-b8ea-0e57965f1ca92023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f82023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd38f31bb-faba-40a8-bc60-2f78f2875ef22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AranelleNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.0beef9d3-8326-48cf-b89a-fa794902c6c12023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-MiliNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP5f3dedb9-a500-4e21-8ffa-0d942243c7902023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.a522aff5-b02f-4e18-bf59-40bb0399e6fe2022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-NymyoNORGESTIMATE AND ETHINYL ESTRADIOLMayne Pharma Inc.b13800f2-618f-468d-b8a5-2fc00595db612022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.198477e0-855a-4a1d-ae0b-407568dd05f82022-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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

Reported adverse events (FAERS/openFDA)#

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