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 4 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC50fe00b3-6610-1cac-e063-6294a90af8ac2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC5100c561-0028-a3c0-e063-6394a90addeb2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.510349d0-6397-7e2b-e063-6394a90a8a682026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPf94a81e2-49cd-430a-acda-1a47d5c5b59b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4a2c8e57-d52d-409f-83d8-731b721bf6132026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack4caf9040-5507-45a4-8f42-231aa925ab8d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackf347d92a-7726-4165-bc3c-f5b37ec86f9f2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.f8c14539-8ed1-406a-9b58-8ba3a7ce7ee32026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966222
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack0210a600-747e-433a-8ba9-11692ecfb54a2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackef7bc627-d37b-470e-b8f7-3c472c930d052026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd0beda93-9454-4846-b5c6-2a9113fb17652026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892255
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack0b9d21d8-9b49-4fd2-b516-b25bc6a6b6712026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892251
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackcaf7825d-f434-472f-94f3-217a412555622026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966249
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.55cebc88-0514-4940-b974-ec7f0467d10e2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966253
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.c7d5b71b-e983-4b1a-bfc2-d2343cf8668c2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966221
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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