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 7 of 15 · 283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PortiaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.c78b236b-85c4-4258-a524-cea08775100c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019
rxcui: 748797
rxcui: 748878
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
FalminaLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCcf6f069e-4b78-4adb-b5be-100b9d85aab72025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
VALTYA 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC207dfcf6-5239-c907-e5fe-35372da57dd92025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VALTYA 1/50ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC1aff28b0-93eb-5e44-9164-d76ffd08cd592025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc32025-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
My WayLEVONORGESTRELProficient Rx LPf2354b0c-dda4-4eb4-93f3-b2d57856a9482025-01-01WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELThirty Madison Inc.6933ae19-4c8f-49a2-96c5-9cdf37ee58242024-12-30WarningsExact identifier
unii: 5W7SIA7YZW
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC2417aee4-6838-4ea6-8e0d-3144f522310c2024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d9252820-131a-4870-8b11-945d1bfd56592024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MiliNORGESTIMATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited76f14485-321d-4d4f-a3b0-aab195fd0dd12024-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
JAIMIESSLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETSXiromed LLCc094e6de-f1e9-9594-43f3-de1c1bb49bdb2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019

Reported adverse events (FAERS/openFDA)#

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