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 5 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
EmzahhNORETHINDRONEAurobindo Pharma Limited197d31d3-eec8-49c7-9640-918ff138fea22023-04-10Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
LyleqNORETHINDRONEAfaxys Pharma, LLCc9f00a3e-c827-4066-bf85-079b3a20f25e2023-03-27Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
IncassiaNORETHINDRONEAurobindo Pharma Limited0b87cef0-610c-469d-92ba-4007f4bc38782021-09-14Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
8382cbc8-a13d-4c17-a076-d878690cb873fe2cb3eb-dcd0-470c-8cf0-78fda554b1f72021-01-25Warnings, Adverse reactionsExact identifier
spl id: 8382cbc8-a13d-4c17-a076-d878690cb873
spl set id: fe2cb3eb-dcd0-470c-8cf0-78fda554b1f7
42ca1455-6e58-4be7-a54b-459af6cced0e5ce0eb18-6e34-4ec0-982b-2bddac3114042020-12-22Warnings, Adverse reactionsExact identifier
spl set id: 5ce0eb18-6e34-4ec0-982b-2bddac311404
NorethindroneNORETHINDRONEProficient Rx LPfb84b86e-5f1f-4c17-8b69-ff695c5faf552019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONEMylan Pharmaceuticals Inc.af851d82-b30f-463b-9dba-0437225dc1ee2018-10-23Boxed 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.