FDA.reportPublic FDA data

NDC 0378-7284-85 - LEVONORGESTREL AND ETHINYL ESTRADIOL 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
0378-7284
Requested NDC
0378-7284-85
Package NDCs from labels
0378-7284-85, 0378-7284-90
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2023-04-20
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.2023-04-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7284-85LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT113
0378-7284-85LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT113
0378-7284-90LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL2 in 1 CARTONKIT213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7284LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 3 package rows20250221_ada28708-ab65-4c07-a695-9141c5ce26bc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7284-85EA - Each0378-72846fc0d49b-0224-41c3-836d-7c1bb1fb9f2e12016-12-07
0378-7284-90EA - Each0378-72845db73028-ca63-4db1-9edc-558882016c6c12016-12-07

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 8 · 150 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 242297
RestartLEVONORGESTRELWinx Health Inc.0cdf198e-c114-b9fa-e063-6294a90a566a2026-02-24WarningsExact identifier
unii: 5W7SIA7YZW
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.47fc432b-2259-47d2-bba9-5e3aae5839902026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 242297
LevonorgestrelLEVONORGESTRELYYBA Corp49008f10-8a70-3c08-e063-6294a90a44a32026-02-03WarningsExact identifier
unii: 5W7SIA7YZW
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA39988aa6-8f68-40e8-9bdd-c40a3bdaad612026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AshlynaLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA407a9f63-9abf-4886-864a-d3dd0e4297622026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.7d82aa5d-aee9-4c72-9b9b-af7adad21f4c2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 810096
rxcui: 248310
rxcui: 242297
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e686b50-8d36-4a13-91a8-d4ad21cdb7352025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
PIMTREADESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNorthstar Rx LLCb716fd2a-b186-447a-85bd-6302284d14e52025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 248310
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLAcella Pharmaceuticals167b12a0-cdff-4081-a0a4-164482c239fa2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
BalcoltraLEVONORGESTREL AND ETHINYL ESTRADIOLAvion Pharmaceuticals752ab698-4b48-4614-8016-d1d33ee7c0072025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
New DayLEVONORGESTRELNorthstar Rx LLC9e8c96f6-ab51-4721-b276-1ca02a7125102025-12-05WarningsExact identifier
unii: 5W7SIA7YZW
My WayLEVONORGESTRELLupin Pharmaceuticals, Inc.3efec61d-e0a6-49c5-9b88-834db6d171fd2025-12-02WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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