FDA.reportPublic FDA data

NDC 0378-7287-85 - 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
0378-7287
Requested NDC
0378-7287-85
Package NDCs from labels
0378-7287-85, 0378-7287-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2022-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mgMylan Pharmaceuticals Inc.2022-08-31HUMAN PRESCRIPTION DRUG LABEL
LEVONORGESTREL AND ETHINYL ESTRADIOL - A-S Medication SolutionsA-S Medication Solutions2018-02-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7287-53LEVONORGESTREL AND ETHINYL ESTRADIOL3 in 1 CARTONKIT314
0378-7287-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT114
0378-7287-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20250221_c3c00dc0-8834-45fb-9f5b-810a98cef59d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7287-53EA - Each0378-7287d20cdebc-3c75-44a1-b637-da1495eadf2d12014-07-02
0378-7287-85EA - Each0378-7287b017bafe-6b4b-4452-8d95-34e60e296aa212018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]2

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 18 · 350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.752f525e-1838-4058-9ab7-2c2d91f86dfd2026-05-20Boxed warning, WarningsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
unii: 5W7SIA7YZW
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
My ChoiceLEVONORGESTRELOHM LABORATORIES INC500d9418-69a8-f4f3-e063-6394a90a9b662026-04-22WarningsExact identifier
unii: 5W7SIA7YZW
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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