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 21 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMAurobindo Pharma Limitedc760d0cc-2245-4914-8c67-d536c41ac90f2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
rxcui: 966270
rxcui: 966249
rxcui: 966225
unii: 9J765S329G
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.cba6bb77-2140-6cba-e053-2995a90aa1b62024-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMHikma Pharmaceuticals USA Inc.6279390b-ee61-4ef9-ac15-25537ca783c12024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.a2157cf0-5c8f-7e69-e053-2a95a90aa0832024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.a215da96-acd9-6b8d-e053-2995a90a7e0d2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCar Pharmaceuticals,Inc.a2194c58-b755-e6b5-e053-2a95a90a36d42024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.1ac856d1-7067-a71d-e063-6294a90acc7c2024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack56c633a9-3f64-46bd-b93f-afbff92b55592024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMTeva Pharmaceuticals, Inc.60cadfd7-82b5-4207-97e1-1dd0655efb272024-06-01Boxed 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
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMDIRECT RXa5f15022-1166-09fe-e053-2a95a90aa2182024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 966224
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8849620a-5e8d-4031-884f-9a2817b050f22024-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPe1b322a6-9161-45b9-bf77-3c44502d5efd2024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Pharmaceuticals Inc.e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc2024-04-15Boxed 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
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepacke486f83b-6cf0-4e7d-99ed-cfd19c4501e12024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd35b5250-c26d-4d67-8a33-2f993b13e3e92024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd6ce9798-7204-41df-9aeb-067000cb08952024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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