FDA.reportPublic FDA data

NDC 0378-7281-85 - LEVONORGESTREL 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
0378-7281
Requested NDC
0378-7281-85
Package NDCs from labels
0378-7281-85, 0378-7281-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-09-15
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.2023-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7281LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250221_af93fc89-c813-4a8c-9909-44729ab25a64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7281-53EA - Each0378-7281b95bb4f7-811a-4cda-a732-258ffeaf0cc112015-05-05
0378-7281-85EA - Each0378-72814e91d0a4-aa5c-4594-a9cc-5db57c503cf712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4

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 2 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
My WayLEVONORGESTRELLupin Pharmaceuticals, Inc.3efec61d-e0a6-49c5-9b88-834db6d171fd2025-12-02WarningsExact identifier
unii: 5W7SIA7YZW
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bb96f0-d5f1-1ec3-e063-6294a90a74b12025-11-26WarningsExact identifier
unii: 5W7SIA7YZW
Julie Morning After PillLEVONORGESTRELJulie Products Inc.40bbad6f-0c54-e4ed-e063-6394a90af3ad2025-11-14WarningsExact identifier
unii: 5W7SIA7YZW
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
MirenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.dcbd6aa2-b3fa-479a-a676-56ea742962fc2025-10-29Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
KyleenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.2e07c155-21e1-4781-9633-ce8bddd470802025-10-23Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
JulieLEVONORGESTRELJulie Products Inc2e9784da-2186-a630-e063-6294a90a84932025-07-14WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.f3f2a41a-a9af-4d63-81d8-33181d12af402025-07-04WarningsExact identifier
unii: 5W7SIA7YZW
AfterPillLEVONORGESTRELSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 068804d284ba4-9cd7-48e4-95b9-cd6d0367bfd12025-05-01WarningsExact identifier
unii: 5W7SIA7YZW
PostDay One-StepLEVONORGESTRELHome Health Brands, LLC01c8c95c-6fbe-4068-915d-74418a6bb5702025-04-23WarningsExact identifier
unii: 5W7SIA7YZW
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Morning After PillLEVONORGESTRELCadence Health Inc2fb59f53-d885-9d4a-e063-6394a90a88cc2025-04-15WarningsExact identifier
unii: 5W7SIA7YZW
EContra One-StepLEVONORGESTRELAfaxys Pharma, LLC94b23c49-dfba-4a70-ada5-e5c212e703c52025-04-08WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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