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 7 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSMayne Pharma Inc.d0d2a9e9-e9ce-4a42-b429-5c1f9a5447952025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 748797
MirenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.dcbd6aa2-b3fa-479a-a676-56ea742962fc2025-10-29Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
KyleenaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.2e07c155-21e1-4781-9633-ce8bddd470802025-10-23Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals Inc.1f8b9aad-f31f-4cda-861d-c08a977fc9232025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
NeconNORETHINDRONE AND ETHINYL ESTRADIOLMayne Pharma Inc.e80714f4-cdfe-4d60-a4e1-b8c7b184cc462025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLMayne Pharma Inc.bff09a7b-aea6-460b-a263-44576e00f5102025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack5bebc7e2-d085-410c-bae1-7d758d3c20162025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
Drospirenone and Ethinyl EstradiolDROSPIRENONE AND ETHINYL ESTRADIOLNorthStar Rx LLCc88c3eb8-3bf5-4004-a7ab-7218cd2f91822025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AyunaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited2b54ce42-db64-46c3-a788-569e21f7ab062025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Aubra EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC61207a91-8b3c-4231-b98f-3cb9f4a4be092025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
AfirmelleLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddd6122cd-b7ba-4fe3-bde5-910882475b672025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
Chateal EQLEVONORGESTREL AND ETHINYL ESTRADIOLAfaxys Pharma, LLC4c59652c-49a6-4eed-b557-9abd3ffac5412025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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