FDA.reportPublic FDA data

NDC 54868-2638-3 - Synthroid

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
54868-2638
Requested NDC
54868-2638-3
Package NDCs from labels
54868-2638-0, 54868-2638-3
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-05-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SYNTHROID® (levothyroxine sodium tablets, USP)Physicians Total Care, Inc.2014-05-05HUMAN 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
54868-2638-02019-09-24C16284748780-19350213a-42f8-c013-e053-90daa90a1393SYNTHROID® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2638-0Synthroid30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2638SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]51 package rows20140507_abe005b2-d962-4ba7-9cb6-a09d35e68ae7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2638-0EA - Each54868-2638cac6f02e-7762-43c3-a43b-ff723131b84912012-07-24
54868-2638-2EA - Each54868-2638c9b8818b-f647-4845-826c-1a183a0a3c8712012-07-24
54868-2638-3EA - Each54868-2638d061a65c-4d3f-4b95-9b9b-18bb8698eb1b12012-07-24
54868-2638-4EA - Each54868-263864179727-a4f1-49a9-a3ea-67c21dccf7fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
ACACIAINACTIVE INGREDIENT5C5403N26OSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ESYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [PHYSICIANS TOTAL CARE, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1USYNTHROID (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 20 · 387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions67f46137-afc4-471b-a6c7-9c2aef92da5d2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.70a9bb5c-2259-405e-8d89-cc1db8c707432026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.6f4998ac-0714-4f5d-8944-9e6902b9f0a62026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions853d9e86-2b5b-4967-8c22-70ad34f034182026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutionsb42fe9dd-8383-4839-9eab-393de388da712026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsfa7dd488-de7e-4f9e-87db-18391b723aad2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions394b1006-c160-4668-8684-82d1c44812022026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions8e11401b-f5c2-42ac-ba63-2e71b5626b7e2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4520fae0-acce-47a0-af9e-f4f16ea6b2682026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions2ce47caf-6ece-429c-b5d7-c47ba69528002026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions99df68ea-4de7-4825-a6d7-894c70d01c282026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4f26f9dc-cf49-4b55-a6f7-f2f579893ee42026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions2b737395-0238-400b-95ff-890b95c984252026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMASCLEMED USA INC.42a26f8a-dc67-42e4-abb0-d2602afb1b7d2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 892251
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 892255
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions1ac29774-2b53-4a3f-97fa-16c2880a08682026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsb717aff6-f754-458d-be87-d12d87c5da002026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions62de26a8-d6fc-463f-abe6-4656228c31422026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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