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 24 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP7ceed5ff-fd41-4ebd-ade7-e31b135231c12022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
8.4% SODIUM BICARBONATE8.4% SODIUM BICARBONATEHF Acquisition Co. LLC, DBA HealthFirst74d8bb7a-9e7a-105f-e053-2a91aa0aec922021-05-03Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP2daab9ce-0570-4fdf-a7bd-01c3178f8cf32021-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP2f0657d5-3e5c-4249-bfaa-7f5ef15286722021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 966220
unii: 9J765S329G
LEVOXYLLEVOTHYROXINE SODIUMPfizer Laboratories Div Pfizer Inc758588c3-c63e-491b-0aa2-4f50d80cb1742020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021301
ndc (product): 60793-853
ndc (product): 60793-852
ndc (product): 60793-850
ndc (product): 60793-855
ndc (product): 60793-854
ndc (product): 60793-851
ndc (product): 60793-856
ndc (product): 60793-858
rxcui: 966190
rxcui: 966157
rxcui: 966200
rxcui: 966164
rxcui: 966248
rxcui: 892251
rxcui: 966194
rxcui: 966184
rxcui: 966175
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 966283
rxcui: 966170
rxcui: 966204
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966211
rxcui: 966225
rxcui: 966253
spl id: e230c170-2a16-47d0-bce7-ac0414c192f7
spl set id: 758588c3-c63e-491b-0aa2-4f50d80cb174
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC388a1f15-8c1c-46a5-997f-7f326f696b592020-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC50b1c8a4-75b6-49c8-80fc-3841ee80b1832020-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d62020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Good Sense Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEL. Perrigo Companybcf32242-de17-4da1-b707-4ce26262eb782020-11-16WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP97e28b00-9913-463f-9de2-08c828edbe672020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP05ab038e-45fa-488e-a05e-12a2dd3564c12020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPb81720f9-2836-4c1d-8691-0f6acef133162020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP3019762c-d480-4530-a3b2-762b523e79612019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP434075d5-a82b-4f17-85e6-4c1922663dbc2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP18c7c63a-642e-47fe-a8ee-12aaf652b2aa2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
UnithroidLEVOTHYROXINE SODIUMAmneal Pharmaceuticals LLC07562e72-7eaa-4ce6-94f0-e08814787e502019-06-19Boxed 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
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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