FDA.reportPublic FDA data

NDC 0378-7281-85 - 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
0378-7281
Requested NDC
0378-7281-85
Package NDCs from labels
0378-7281-85, 0378-7281-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-09-15
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.2023-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7281LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250221_af93fc89-c813-4a8c-9909-44729ab25a64.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7281-53EA - Each0378-7281b95bb4f7-811a-4cda-a732-258ffeaf0cc112015-05-05
0378-7281-85EA - Each0378-72814e91d0a4-aa5c-4594-a9cc-5db57c503cf712022-06-06

DailyMed Socrata Ingredients#

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

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 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200490
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.5c509934-8c11-4d7f-8506-5971c37cfc222024-09-06WarningsExact identifier
unii: 5W7SIA7YZW
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
My WayLEVONORGESTRELNuCare Pharmaceuticals,Inc.6598a875-8be8-0928-e053-2a91aa0a064d2024-06-06WarningsExact identifier
unii: 5W7SIA7YZW
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
PostDay One-StepLEVONORGESTRELRapha Pharmaceuticals, Inc.6f7f5697-acb6-ea95-e053-2991aa0ae7c72023-11-21WarningsExact identifier
unii: 5W7SIA7YZW
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Plan B One-StepLEVONORGESTRELA-S Medication Solutionsfcc7ba8e-ad54-4efe-87e4-5eb0fbf4f0642023-10-24WarningsExact identifier
unii: 5W7SIA7YZW
bb7e6361-692e-4bf9-9bfa-da7da696cc5aaf93fc89-c813-4a8c-9909-44729ab25a642023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: bb7e6361-692e-4bf9-9bfa-da7da696cc5a
spl set id: af93fc89-c813-4a8c-9909-44729ab25a64
LevonorgestrelLEVONORGESTRELXiromed LLC626a2333-ff56-ef28-a287-b33bacc0302a2023-09-05WarningsExact identifier
unii: 5W7SIA7YZW
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD

Reported adverse events (FAERS/openFDA)#

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