FDA.reportPublic FDA data

NDC 50102-100-01 - LYZA

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
50102-100
Requested NDC
50102-100-01
Package NDCs from labels
50102-100-00, 50102-100-01, 50102-100-48, 50102-100-10, 50102-100-03
Manufacturer
Afaxys Pharma LLC | Mylan Laboratories Limited
Effective date
2021-01-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LYZA - Afaxys Pharma LLC | Mylan Laboratories LimitedAfaxys Pharma LLC | Mylan Laboratories Limited2021-01-25HUMAN PRESCRIPTION DRUG LABEL
Lyza® Norethindrone Tablets USP, 0.35 mgRPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50102-100-032023-01-30C16284748780-1f386c649-a411-0266-e053-dadaa90a7c1aLyza® Norethindrone Tablets USP, 0.35 mg
50102-100-482023-01-30C16284748780-1f386c649-a411-0266-e053-dadaa90a7c1aLyza® Norethindrone Tablets USP, 0.35 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50102-100-00LYZA28 in 1 BLISTER PACKTABLET2813
50102-100-01LYZA1 in 1 PACKAGETABLET113
50102-100-03LYZA03 in 1 CARTONTABLET0313
50102-100-10LYZA1 in 1 PACKAGETABLET113
50102-100-48LYZA48 in 1 CASETABLET4813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50102-100LYZA (NORETHINDRONE) TABLET [AFAXYS PHARMA LLC]13Legacy NDC, 5 package rows20210128_fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-100-01EA - Each50102-1002e83f27d-1c30-46f3-84cd-876b7fde59f012013-08-02
50102-100-03EA - Each50102-100bc553cd9-9974-481c-9c5d-aab9d7e9491112017-04-05
50102-100-10EA - Each50102-100a6286c6e-7dfb-4afa-a076-3e55e224ae8f12017-08-11
50102-100-48EA - Each50102-100b2f9741e-ee53-47bc-8aad-bd39ed58901e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
NORETHINDRONEACTIVE MOIETYT18F433X4SLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94ELYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1ULYZA (NORETHINDRONE) TABLET [AFAXYS INC.]6

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 3 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
DEBLITANENORETHINDRONENorthstar Rx LLCe75367ff-78af-4bd2-a99d-d291cb1d21eb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
SHAROBELNORETHINDRONENorthstar Rx LLCa96f5194-ad2a-4783-a9a9-22a288caff252025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
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
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsExact identifier
application number: ANDA200980
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S

Reported adverse events (FAERS/openFDA)#

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