FDA.reportPublic FDA data

NDC 54868-4535-0 - 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
54868-4535-0
Package NDCs from labels
54868-4535-1, 54868-4535-0
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 6 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack2ecaa38f-8a6f-4536-8033-251d2c52ae642026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack4461bc9f-35db-4211-82ab-7671cf4dc14b2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack66bb0ba9-cd63-4817-907f-7b8ad5dc66852026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Tirosint SOLLEVOTHYROXINE SODIUMIBSA Pharma Inc.5d378add-f13d-40f2-99dc-0f2340ab44b72026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions70853a82-ba3b-4663-9f78-6791ca72ba9f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8ac112c3-1e06-4fdb-a7af-2ee988de5b152026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack69fb5cd6-90ba-487d-a754-07c664a1fdd12026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
TirosintLEVOTHYROXINE SODIUMIBSA Pharma Inc.7a7ade79-0165-4e31-b84e-667416c00c7e2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMYARAL Pharma Inc.d28d7202-1278-0486-e053-2995a90af2862026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7c8a6441-3c12-46ae-bb3b-a320d80045b62026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions008de8fd-150f-4022-8ccb-c8bfa94875c72026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions991399a4-ff94-44d0-b1ba-1f89e77594982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions87333260-fe57-4d99-886c-7c66cb0638982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions52a07ade-4098-477d-874e-dd692667041e2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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