FDA.reportPublic FDA data

NDC 0378-7285-85 - LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

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
0378-7285
Requested NDC
0378-7285-85
Package NDCs from labels
0378-7285-85, 0378-7285-90
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEVONORGESTREL AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-02-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7285LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250221_e5eb2533-cc31-43a8-8fca-d46d72a59530.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7285-85EA - Each0378-728571b51272-cc18-4724-a617-136b030b6d6312022-06-06
0378-7285-90EA - Each0378-72855a8bbb84-5882-4c96-b33c-3f2ad100108b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5

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 3 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EContra One-StepLEVONORGESTRELAfaxys Pharma, LLC94b23c49-dfba-4a70-ada5-e5c212e703c52025-04-08WarningsExact identifier
unii: 5W7SIA7YZW
JulieLEVONORGESTRELJulie Products Inc.8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae82025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
ITHAPPENZ MORNING AFTERLEVONORGESTRELAurohealth LLC5ee40793-0121-4b8f-b20d-3178bbe262e22025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
JulieLEVONORGESTRELJulie Products Inc.8d20510f-a4e8-4d4b-a96a-f0da917858332025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
Econ Morning AfterLEVONORGESTRELAurohealth LLC177daa65-2e7d-4ff4-887e-b927d6ed88252025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELLEADER/ CARDINAL HEALTH 110, INC.c7d3a74e-37c4-4c49-861c-64ef363d5a532025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
Fem Choice morning afterLEVONORGESTRELAurohealth LLC14051537-9d6c-4f73-a6e9-5eed554bbf652025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
AMAZON BASIC CARE LEVONORGESTRELLEVONORGESTRELAmazon.com Services LLC10ecae6f-386f-e199-e063-6294a90a680b2025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
Athentia NextLEVONORGESTRELAurohealth LLC34e5aa53-3943-4e2f-93aa-b5a4d779a7032025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
After BangerLEVONORGESTRELAurohealth LLC791a2461-971c-4191-8905-5a449c600a492025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Morning After PillLEVONORGESTRELCadence Health Incfc5d29bb-4a4b-e61e-e053-6394a90a8a622025-02-14WarningsExact identifier
unii: 5W7SIA7YZW
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
My WayLEVONORGESTRELProficient Rx LPf2354b0c-dda4-4eb4-93f3-b2d57856a9482025-01-01WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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