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 9 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE LEVONORGESTRELLEVONORGESTRELAmazon.com Services LLC10ecae6f-386f-e199-e063-6294a90a680b2025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
Athentia NextLEVONORGESTRELAurohealth LLC34e5aa53-3943-4e2f-93aa-b5a4d779a7032025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
After BangerLEVONORGESTRELAurohealth LLC791a2461-971c-4191-8905-5a449c600a492025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
PortiaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.c78b236b-85c4-4258-a524-cea08775100c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FalminaLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCcf6f069e-4b78-4adb-b5be-100b9d85aab72025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Morning After PillLEVONORGESTRELCadence Health Incfc5d29bb-4a4b-e61e-e053-6394a90a8a622025-02-14WarningsExact identifier
unii: 5W7SIA7YZW
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Dairy-Grain-NightshadesIRIS 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.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: J2B2A4N98G
VALTYA 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC207dfcf6-5239-c907-e5fe-35372da57dd92025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VALTYA 1/50ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLXiromed LLC1aff28b0-93eb-5e44-9164-d76ffd08cd592025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Mono-LinyahNORGESTIMATE AND ETHINYL ESTRADIOLNorthstar Rx LLC84a20017-344b-4684-a915-c85a55fcbbcb2025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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