FDA.reportPublic FDA data

NDC 54868-4535-2 - LEVOXYL

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
54868-4535
Requested NDC
54868-4535-2
Package NDCs from labels
54868-4535-1, 54868-4535-2
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levoxyl ® (levothyroxine sodium tablets, USP)Physicians Total Care, Inc.2013-08-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-4535-12019-09-24C16284748780-19350213a-44f6-c013-e053-90daa90a1393Levoxyl ® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4535-1LEVOXYL30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4535LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]51 package rows20130820_951c6e16-7251-42ed-ac19-d8367a6aee4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-4535-0EA - Each54868-4535b4aef346-caf3-4da3-8d9d-1925e154fab512012-07-24
54868-4535-1EA - Each54868-4535e84f8d98-5131-4014-927f-495343aa1e7212012-07-24
54868-4535-2EA - Each54868-45352dc70794-405b-4bee-8a56-d732a9fcb6e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5

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 15 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.ff7f5eff-4c90-4aa0-8915-704f92dea8aa2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAOLE, SODIUM BICARBONATERiley Consumer Care LLC8d00c19a-d86b-4a2f-8791-b320ad3ca7812025-07-15WarningsExact identifier
unii: 8MDF5V39QO
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.412fc3f4-d9e0-49c5-b042-a6010aea7e5e2025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsExact identifier
unii: 8MDF5V39QO
THYQUIDITYLEVOTHYROXINE SODIUMOliva Therapeutics, LLC0c839877-50e4-455f-9b6c-462efb09cb962025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.884f9fa1-58aa-4ff7-934f-106a0470e7472025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
Schuessler Tissue Salts Calc Sulph Blood Cleanser 3CALCAREA SULPHURICAMartin & Pleasance Pty Ltd0393cf03-4a68-4d01-bfb3-498e5ad626b12025-07-01WarningsExact identifier
unii: 4846Q921YM
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMMajor Pharmaceuticals333642fd-93ae-4dc0-9c83-6d6b163c1c742025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 966222
rxcui: 892246
rxcui: 966221
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMAmerican Health Packaging38af4e36-b26b-485d-a6f3-7fbcf6072a0f2025-06-16Boxed 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
INFANT 4.2% SODIUM BICARBONATEINFANT 4.2% SODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst78c25911-0042-664e-e053-2a91aa0a57a12025-06-16Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf0680426-3581-400c-8ab5-5e6f18d0cabc2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsb4654497-c986-4792-9b6b-0a791c7c205b2025-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd2025-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions247f4d1d-6e65-4f81-a377-4dd88ae16dbb2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions70dddaf0-f495-495f-95de-36e9efa2e3732025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions91afb351-f067-49a2-bdf0-336ea209718d2025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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