FDA.reportPublic FDA data

NDC 54868-4176-0 - 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
54868-4176
Requested NDC
54868-4176-0
Package NDCs from labels
54868-4176-1, 54868-4176-2, 54868-4176-0
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
54868-4176-12019-09-24C16284748780-19350213a-44f6-c013-e053-90daa90a1393Levoxyl ® (levothyroxine sodium tablets, USP)
54868-4176-22019-09-24C16284748780-19350213a-44f6-c013-e053-90daa90a1393Levoxyl ® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4176-1LEVOXYL30 in 1 BOTTLETABLET305
54868-4176-2LEVOXYL90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4176LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]52 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
54868-4176-0EA - Each54868-417626705e2b-053a-41aa-b860-224da9bb99e112012-07-24
54868-4176-1EA - Each54868-417671dbaaed-ba57-47de-8e5a-4540db2e674a12012-07-24
54868-4176-2EA - Each54868-4176a4aa8e7f-93ce-400f-8acb-f2dd55e9c5ff12012-07-24

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 8 of 25 · 483 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADRIAN BICARBONATO SODIUM BICARBONATE USP-4 oz, 8 oz and 16 ozSODIUM BICARBONATEEvi Labs4979a339-4ad4-9cdd-e063-6394a90a0acc2026-01-28WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCffc34bc6-5de5-addb-e053-6294a90a25be2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.49136b34-1bc1-ec4e-e063-6394a90ac9dd2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf2bed4e7-86e9-430e-80d9-7bd7cfcf9bf52026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions8f7dc71e-4a48-4ba5-945b-f340ff51636e2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions36af0286-e447-4098-b3f2-772debd586672026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse8142948-2bde-4f4b-931e-da43e91f2d592026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd29bc0fd-5587-4a70-a505-f5aee1f115a62026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd5b11dac-1acd-4aa2-b837-e3b90d4f69222026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf6c92836-95e1-1402-e053-6394a90a2f5e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 8MDF5V39QO
D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PUROSODIUM BICARBONATEEvi Labs485f9eb1-6535-c47c-e063-6394a90ae32c2026-01-14WarningsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse2291336-1188-48f4-af52-d12ac892f80f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions98d7ce2b-a248-4ed0-a2ec-d28ba623531e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.59a99739-2da5-46a7-8811-1169123bed9b2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.579b1935-77f5-4381-9cb0-e0130e4834e82026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.4e6dce46-cbf5-4353-9d0c-36b6f857197a2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMLannett Company, Inca8db0f7d-8863-9309-e053-2995a90a284a2026-01-08Boxed 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
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
unii: 8MDF5V39QO
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.3d737f79-7fc9-4221-e063-6394a90ac9aa2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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