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 8 of 15 · 283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 748797
KalligaDESOGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddbe9f9ab-2e38-49e3-bb1f-c8a12d03076a2024-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NYLIA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions4ade84c1-e172-443f-aac7-0e8407aaa7de2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JoyeauxLEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC655b2c93-cfae-d44f-c128-c816bbd88e452024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019
rxcui: 748797
SIMLIYADESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited4161f614-6e55-4114-87f7-19bb77f6b09b2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP411e6e51-b435-4f86-b39f-3377f009b0e92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.5c509934-8c11-4d7f-8506-5971c37cfc222024-09-06WarningsExact identifier
unii: 5W7SIA7YZW
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019
rxcui: 748797
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 748797
My WayLEVONORGESTRELNuCare Pharmaceuticals,Inc.6598a875-8be8-0928-e053-2a91aa0a064d2024-06-06WarningsExact identifier
unii: 5W7SIA7YZW
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSDr. Reddys Laboratories Inc.fb636d42-cc1d-47f7-974d-c97c79207f3e2024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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