FDA.reportPublic FDA data

NDC 0781-5183-01 - 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
0781-5183
Requested NDC
0781-5183-01
Package NDCs from labels
0781-5183-92, 0781-5183-10, 0781-5183-01
Manufacturer
Bryant Ranch Prepack
Effective date
2021-11-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine sodium - Bryant Ranch PrepackBryant Ranch Prepack2021-11-11HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - Bryant Ranch PrepackBryant Ranch Prepack2021-09-16HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - REMEDYREPACK INC.REMEDYREPACK INC.2021-07-13HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2021-07-01HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodiumSandoz Inc. | Neolpharma, Inc. | Neolpharma, Inc | Patheon Puerto Rico, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - Bryant Ranch PrepackBryant Ranch Prepack2020-09-20HUMAN PRESCRIPTION DRUG LABEL
LEVOTHYROXINE SODIUM - Direct_RxDirect_Rx2019-09-06HUMAN PRESCRIPTION DRUG LABEL
LEVOTHYROXINE SODIUM - Direct_RxDirect_Rx2019-08-01HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine sodium - Unit Dose ServicesUnit Dose Services2018-10-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5183-01EA - Each0781-518365b3c9c8-3324-4e09-88b3-382cf6e75d6e12012-07-24
0781-5183-92EA - Each0781-51833b904dbe-52e7-4d1e-b5ac-7fd80997795712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [SANDOZ INC.]11
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]2

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 22 of 43 · 855 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
application number: NDA021342
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: 966222
rxcui: 966221
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
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
rxcui: 966253
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
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Institutional Inc.5723c7a7-2a1d-4ab6-bf39-b2165ae781a62025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
rxcui: 966221
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.398a00d0-1247-4f6f-b4c1-dade399cc4172025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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