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 14 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LP5b684f8f-9610-4449-a213-f70bb4a04b8b2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited867c5630-51be-4469-bf79-6a5cd4302cfa2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
IntrovaleLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.f5bc2427-3a18-e3e6-a058-210688e9c4462022-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4e1927bd-378d-45dc-8b18-3dd57ccd2cb62022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Reclipsen 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a1e00bc6-7487-4057-9dcc-d0e2327d1d122022-01-04Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cb2021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749736
rxcui: 238015
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.563297dc-f27b-46e3-83de-bade17473d622021-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LessinaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a5fd1b3a-019c-4871-95b3-a45bbbd46f822021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.47263647-a9ac-40e4-83c0-d6500fa458cd2021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a9e08f9b-9862-4c2c-8302-53dc82d851262021-12-15Warnings, Adverse reactionsExact identifier
rxcui: 748797
CyonanzNORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited2bd1b72e-fba5-4275-a02a-ed08a5434a922021-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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