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 6 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Option 2LEVONORGESTRELL. Perrigo Company9b9e9352-3e4d-4ec3-96aa-8fd58d82fe962020-07-30WarningsExact identifier
unii: 5W7SIA7YZW
AfterPlanLEVONORGESTRELSUN PHARMACEUTICAL INDUSTRIES, INC.c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a2018-10-26WarningsExact identifier
unii: 5W7SIA7YZW
Morning AfterLEVONORGESTRELRapha Pharmaceuticals, Inc.677aa953-3c30-4ce5-e053-2991aa0ab2b22018-03-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELNovel Laboratories, Inc.ac13a073-a33a-45f7-8483-eecc9190195f2017-09-15Exact identifier
unii: 5W7SIA7YZW
My WayLEVONORGESTRELLupin Pharmaceuticals,Inc.ec01077e-ac3c-424a-9edc-0854fe0a2e0d2016-06-17WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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