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 5 of 15 · 290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA6d85f252-307c-4aa8-9572-1e74c98192832025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ENSKYCEDESOGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.799fa1d8-4e7b-4b5e-844d-d638896a4b022025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.bc402baa-5de4-4149-9857-081a9b4eb2802025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.c25cd86c-2940-475a-9628-ee75b0294e8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e686b50-8d36-4a13-91a8-d4ad21cdb7352025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
NikkiDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.9aff6034-044c-466d-bf52-18a998d47f662025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PIMTREADESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNorthstar Rx LLCb716fd2a-b186-447a-85bd-6302284d14e52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TurqozNORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.5eecfd2c-4bda-4349-b634-199a354fa9962025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 1/35NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCbfadc9b6-1dd6-4bf3-af5f-b50fbdae55d32025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonestLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCbe7000f1-5bf1-4de5-a256-e4436c37f0a12025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLCb71a2b34-95bf-4430-83a0-1a4d1218ea3c2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749736
rxcui: 238015
ElinestNORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCaa7f4a83-71cf-4306-b0a1-01784f67bae22025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SETLAKINLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCb7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.35eb35e6-d9a0-4472-94ac-aa470ccba5672025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.a8955f3b-afc9-4ef0-8946-9c97ab5b2e052025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201886
ndc (package): 68180-875-73
ndc (package): 68180-495-74
ndc (package): 68180-500-74
ndc (product): 68180-875
rxcui: 748797
rxcui: 749736
rxcui: 238015
rxcui: 1485332
spl id: c44722bd-9db7-4ea4-b150-7d514b1bc4f7
spl set id: 175ce5c4-d332-4c97-a0b8-10821dc813ef

Reported adverse events (FAERS/openFDA)#

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