FDA.reportPublic FDA data

NDC 71858-0010-04 - Tirosint

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
71858-0010
Requested NDC
71858-0010-04
Package NDCs from labels
71858-0010-4, 71858-0010-1, 71858-0010-2, 71858-0010-04
Manufacturer
IBSA Pharma Inc.
Effective date
2026-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tirosint - IBSA Pharma Inc.IBSA Pharma Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0010-1Tirosint1 in 1 CARTONCAPSULE113
71858-0010-1Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-2Tirosint3 in 1 CARTONCAPSULE313
71858-0010-2Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint10 in 1 BLISTER PACKCAPSULE1013
71858-0010-4Tirosint3 in 1 CARTONCAPSULE313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0010TIROSINT (LEVOTHYROXINE SODIUM) CAPSULE [IBSA PHARMA INC.]11Current NDC, Legacy NDC, 6 package rows20241027_7a7ade79-0165-4e31-b84e-667416c00c7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0010-4EA - Each71858-00108f761cf5-7112-4857-b7b7-8b5c293cc31912018-12-13

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 9 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.70a9bb5c-2259-405e-8d89-cc1db8c707432026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMPD-Rx Pharmaceuticals, Inc.6f4998ac-0714-4f5d-8944-9e6902b9f0a62026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions853d9e86-2b5b-4967-8c22-70ad34f034182026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutionsb42fe9dd-8383-4839-9eab-393de388da712026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsfa7dd488-de7e-4f9e-87db-18391b723aad2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions394b1006-c160-4668-8684-82d1c44812022026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions8e11401b-f5c2-42ac-ba63-2e71b5626b7e2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4520fae0-acce-47a0-af9e-f4f16ea6b2682026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions2ce47caf-6ece-429c-b5d7-c47ba69528002026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions99df68ea-4de7-4825-a6d7-894c70d01c282026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions4f26f9dc-cf49-4b55-a6f7-f2f579893ee42026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions2b737395-0238-400b-95ff-890b95c984252026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMASCLEMED USA INC.42a26f8a-dc67-42e4-abb0-d2602afb1b7d2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions1ac29774-2b53-4a3f-97fa-16c2880a08682026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsb717aff6-f754-458d-be87-d12d87c5da002026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions62de26a8-d6fc-463f-abe6-4656228c31422026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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