FDA.reportPublic FDA data

NDC 0378-6550-85 - 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
0378-6550
Requested NDC
0378-6550-85
Package NDCs from labels
0378-6550-85, 0378-6550-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2022-07-31
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, 0.15 mg/30 mcg Rx onlyMylan Pharmaceuticals Inc.2022-07-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-6550-53LEVONORGESTREL AND ETHINYL ESTRADIOL3 in 1 CARTONKIT319
0378-6550-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT119
0378-6550-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]19Legacy NDC, 3 package rows20250221_27178b07-42bd-496d-aebb-d9428664ee72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6550-53EA - Each0378-65507c39e2f5-8f91-4700-a739-ebb3ab36f98512013-02-13
0378-6550-85EA - Each0378-65501b7d2373-4131-4aeb-ae56-9baaebf516dc12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) 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 4 of 15 · 283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e686b50-8d36-4a13-91a8-d4ad21cdb7352025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
PhilithNORETHINDRONE AND ETHINYL ESTRADIOL TABLETSNorthstar Rx LLC77b8d3ef-f3ac-4148-84f0-f6cb327c9f782025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748797
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
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: 238019
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
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
VyfemlaNORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.175ce5c4-d332-4c97-a0b8-10821dc813ef2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JuleberDESOGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCde9a2d1b-15f6-453f-b36b-1c2a43c4918d2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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

Reported adverse events (FAERS/openFDA)#

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