FDA.reportPublic FDA data

NDC 42292-040-01 - Levothyroxine Sodium

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
42292-040
Requested NDC
42292-040-01
Package NDCs from labels
42292-040-01, 42292-040-20
Manufacturer
Mylan Institutional Inc.
Effective date
2025-07-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine Sodium - Mylan Institutional Inc.Mylan Institutional Inc.2025-07-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42292-040-01Levothyroxine Sodium1 in 1 BLISTER PACKTABLET111
42292-040-20Levothyroxine Sodium100 in 1 CARTONTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42292-040LEVOTHYROXINE SODIUM TABLET [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20241006_cd69c192-cd3f-47e6-b0a6-c536ffed5c4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-040-01EA - Each42292-040a1f03f74-f346-4e00-92cb-a347740b7a1112017-03-06
42292-040-20EA - Each42292-040bfae7927-4a5f-4b55-8334-f695f1110f9512017-03-06

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 23 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEAcuseplanet Inc3c04778b-9535-856e-e063-6294a90aa8682025-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Silica Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltdf70dcf90-bde9-404d-9ede-4113553ccbff2025-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.609352a9-740f-4874-997b-60b58d0c2b8a2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP9e588c43-b9b5-478e-99f7-e197add3cd262025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackc1b0fbad-5816-4152-ab59-05079e8c21482025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack9e3bffb9-f66e-4c73-befc-e60d769f66102025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 892251
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: ETJ7Z6XBU4
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.64aaeba7-1013-44a4-96fc-b876016897b32025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
SILICA MARINASILICON DIOXIDEBoiron3aada26e-6a8e-f545-e063-6394a90a9f802025-07-24Exact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Institutional Inc.cd69c192-cd3f-47e6-b0a6-c536ffed5c4b2025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076187
ndc (package): 42292-039-20
ndc (package): 42292-041-01
ndc (package): 42292-038-01
ndc (package): 42292-041-20
ndc (package): 42292-039-01
ndc (package): 42292-038-20
ndc (package): 42292-040-20
ndc (package): 42292-040-01
ndc (product): 42292-041
ndc (product): 42292-038
ndc (product): 42292-039
ndc (product): 42292-040
ndc11 (package): 42292004001
rxcui: 966248
rxcui: 966270
rxcui: 966249
rxcui: 966253
spl id: 3a991bf1-d9aa-b137-e063-6294a90af2cf
spl set id: cd69c192-cd3f-47e6-b0a6-c536ffed5c4b
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutionscfab474d-3272-41fd-a8ec-762dd1a84fa62025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutionsb9a50170-ac0b-483e-9e85-1d03b12e4f7d2025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.0fa2e2f5-401b-45c1-b6a5-d02f6faf509d2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Institutional Inc.5723c7a7-2a1d-4ab6-bf39-b2165ae781a62025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076187
rxcui: 966222
rxcui: 892246
rxcui: 966221
rxcui: 966224
rxcui: 966220
rxcui: 966225
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.398a00d0-1247-4f6f-b4c1-dade399cc4172025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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