FDA.reportPublic FDA data

NDC 51862-028-01 - Lutera

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
51862-028
Requested NDC
51862-028-01
Package NDCs from labels
51862-028-01, 51862-028-06
Manufacturer
Mayne Pharma Inc. | Patheon, Inc.
Effective date
2025-07-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP)Mayne Pharma Inc. | Patheon, Inc.2025-07-28HUMAN PRESCRIPTION DRUG LABEL
Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP)RPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-028-01Lutera1 in 1 BLISTER PACKKIT17
51862-028-06Lutera6 in 1 CARTONKIT67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-028LUTERA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]6Current NDC, Legacy NDC, 2 package rows20220323_b91ad328-f2f4-4f7d-82d3-daaada95f509.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-028-01EA - Each51862-02893fd91c7-fa83-4307-a955-47d7b5b9a8b212016-10-06
51862-028-06EA - Each51862-02816806c94-b9e7-494e-adb0-f889c569e65312016-10-06

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 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b91ad328-f2f4-4f7d-82d3-daaada95f5092025-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA076625
ndc (package): 51862-028-06
ndc (package): 51862-028-01
ndc (product): 51862-028
ndc11 (package): 51862002801
rxcui: 748797
rxcui: 751884
rxcui: 242297
rxcui: 748868
spl id: bf6c876c-12de-48e8-a9f2-cf74ee3338f1
spl set id: b91ad328-f2f4-4f7d-82d3-daaada95f509
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: J2B2A4N98G
LevoraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.31679b9f-58c9-4bf1-8c2c-f5a216ff4cd32025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SRONYXLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b0c1a495-4cd7-4664-8fe4-714812f53c712025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
JulieLEVONORGESTRELJulie Products Inc2e9784da-2186-a630-e063-6294a90a84932025-07-14WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.f3f2a41a-a9af-4d63-81d8-33181d12af402025-07-04WarningsExact identifier
unii: 5W7SIA7YZW
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack241fb1e2-c0da-47b8-b502-2cb17976d7c02025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YazDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.065f33e4-b587-4e66-b896-ca9ab7b7c8762025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfterPillLEVONORGESTRELSyzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 068804d284ba4-9cd7-48e4-95b9-cd6d0367bfd12025-05-01WarningsExact identifier
unii: 5W7SIA7YZW
PostDay One-StepLEVONORGESTRELHome Health Brands, LLC01c8c95c-6fbe-4068-915d-74418a6bb5702025-04-23WarningsExact identifier
unii: 5W7SIA7YZW
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Morning After PillLEVONORGESTRELCadence Health Inc2fb59f53-d885-9d4a-e063-6394a90a88cc2025-04-15WarningsExact identifier
unii: 5W7SIA7YZW
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.00dd9b78-dd90-414b-b241-7619aa9d1ed22025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EContra One-StepLEVONORGESTRELAfaxys Pharma, LLC94b23c49-dfba-4a70-ada5-e5c212e703c52025-04-08WarningsExact identifier
unii: 5W7SIA7YZW
JulieLEVONORGESTRELJulie Products Inc.8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae82025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
ITHAPPENZ MORNING AFTERLEVONORGESTRELAurohealth LLC5ee40793-0121-4b8f-b20d-3178bbe262e22025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
JulieLEVONORGESTRELJulie Products Inc.8d20510f-a4e8-4d4b-a96a-f0da917858332025-04-07WarningsExact identifier
unii: 5W7SIA7YZW
Econ Morning AfterLEVONORGESTRELAurohealth LLC177daa65-2e7d-4ff4-887e-b927d6ed88252025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELLEADER/ CARDINAL HEALTH 110, INC.c7d3a74e-37c4-4c49-861c-64ef363d5a532025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
Fem Choice morning afterLEVONORGESTRELAurohealth LLC14051537-9d6c-4f73-a6e9-5eed554bbf652025-04-04WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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