FDA.reportPublic FDA data

NDC 71858-0145-4 - Tirosint SOL

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
71858-0145
Requested NDC
71858-0145-4
Package NDCs from labels
71858-0145-6, 71858-0145-4, 71858-0145-5, 71858-0145-1, 71858-0145-2
Manufacturer
IBSA Pharma Inc.
Effective date
2026-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tirosint SOL - IBSA Pharma Inc.IBSA Pharma Inc.2026-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0145-1TirosintSOL2 in 1 CARTONSOLUTION218
71858-0145-2TirosintSOL6 in 1 CARTONSOLUTION618
71858-0145-4TirosintSOL5 in 1 POUCHSOLUTION518
71858-0145-5TirosintSOL6 in 1 CARTONSOLUTION618
71858-0145-6TirosintSOL1 mL in 1 AMPULESOLUTION118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0145TIROSINT SOL (LEVOTHYROXINE SODIUM) SOLUTION [IBSA PHARMA INC.]16Current NDC, Legacy NDC, 5 package rows20241025_5d378add-f13d-40f2-99dc-0f2340ab44b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0145-4ML - Milliliter71858-01451679fc7c-9749-4750-a19c-348e8f02609912019-03-12
71858-0145-5ML - Milliliter71858-014505d27637-2d68-4488-ba32-721fc9a5f0ba12019-03-12

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 7 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack0b9d21d8-9b49-4fd2-b516-b25bc6a6b6712026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackcaf7825d-f434-472f-94f3-217a412555622026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.55cebc88-0514-4940-b974-ec7f0467d10e2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.c7d5b71b-e983-4b1a-bfc2-d2343cf8668c2026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP0235176b-ec39-44c4-a9e1-e0729a7989fa2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP7d07e932-7372-4c17-aa53-55087107fa522026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack73c3d459-dcbf-4458-8edd-2637275a96a12026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack2ecaa38f-8a6f-4536-8033-251d2c52ae642026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack4461bc9f-35db-4211-82ab-7671cf4dc14b2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack66bb0ba9-cd63-4817-907f-7b8ad5dc66852026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Tirosint SOLLEVOTHYROXINE SODIUMIBSA Pharma Inc.5d378add-f13d-40f2-99dc-0f2340ab44b72026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA206977
ndc (package): 71858-0105-4
ndc (package): 71858-0115-4
ndc (package): 71858-0117-2
ndc (package): 71858-0160-1
ndc (package): 71858-0135-6
ndc (package): 71858-0140-1
ndc (package): 71858-0110-2
ndc (package): 71858-0155-5
ndc (package): 71858-0125-1
ndc (package): 71858-0113-4
ndc (package): 71858-0150-2
ndc (package): 71858-0120-5
ndc (package): 71858-0110-6
ndc (package): 71858-0130-2
ndc (package): 71858-0117-5
ndc (package): 71858-0150-6
ndc (package): 71858-0113-5
ndc (package): 71858-0115-1
ndc (package): 71858-0140-6
ndc (package): 71858-0155-6
ndc (package): 71858-0112-5
ndc (package): 71858-0150-1
ndc (package): 71858-0160-5
ndc (package): 71858-0130-5
ndc (package): 71858-0130-1
ndc (package): 71858-0125-2
ndc (package): 71858-0145-2
ndc (package): 71858-0112-2
ndc (package): 71858-0117-4
ndc (package): 71858-0112-4
ndc (package): 71858-0130-4
ndc (package): 71858-0160-4
ndc (package): 71858-0125-6
ndc (package): 71858-0135-5
ndc (package): 71858-0115-2
ndc (package): 71858-0150-4
ndc (package): 71858-0120-6
ndc (package): 71858-0145-4
ndc (package): 71858-0150-5
ndc (package): 71858-0145-5
ndc (package): 71858-0130-6
ndc (package): 71858-0135-1
ndc (package): 71858-0125-4
ndc (package): 71858-0115-5
ndc (package): 71858-0120-2
ndc (package): 71858-0113-2
ndc (package): 71858-0117-1
ndc (package): 71858-0135-4
ndc (package): 71858-0120-1
ndc (package): 71858-0105-6
ndc (package): 71858-0125-5
ndc (package): 71858-0110-4
ndc (package): 71858-0145-6
ndc (package): 71858-0105-2
ndc (package): 71858-0160-2
ndc (package): 71858-0110-1
ndc (package): 71858-0113-1
ndc (package): 71858-0140-4
ndc (package): 71858-0112-6
ndc (package): 71858-0115-6
ndc (package): 71858-0140-5
ndc (package): 71858-0145-1
ndc (package): 71858-0105-5
ndc (package): 71858-0120-4
ndc (package): 71858-0117-6
ndc (package): 71858-0113-6
ndc (package): 71858-0155-1
ndc (package): 71858-0105-1
ndc (package): 71858-0110-5
ndc (package): 71858-0155-2
ndc (package): 71858-0155-4
ndc (package): 71858-0112-1
ndc (package): 71858-0160-6
ndc (package): 71858-0135-2
ndc (package): 71858-0140-2
ndc (product): 71858-0120
ndc (product): 71858-0140
ndc (product): 71858-0110
ndc (product): 71858-0130
ndc (product): 71858-0135
ndc (product): 71858-0115
ndc (product): 71858-0105
ndc (product): 71858-0150
ndc (product): 71858-0145
ndc (product): 71858-0113
ndc (product): 71858-0160
ndc (product): 71858-0112
ndc (product): 71858-0125
ndc (product): 71858-0117
ndc (product): 71858-0155
ndc11 (package): 71858014504
rxcui: 2056478
rxcui: 2056472
rxcui: 2566615
rxcui: 2056510
rxcui: 2056494
rxcui: 2056492
rxcui: 2056466
rxcui: 2566610
rxcui: 2056488
rxcui: 2056480
rxcui: 2056468
rxcui: 2056486
rxcui: 2056470
rxcui: 2056476
rxcui: 2056490
rxcui: 2056504
rxcui: 2056506
rxcui: 2566608
rxcui: 2056482
rxcui: 2566613
rxcui: 2056508
rxcui: 2056474
rxcui: 2566619
rxcui: 2056484
rxcui: 2566617
rxcui: 2056496
rxcui: 2056462
rxcui: 2056500
rxcui: 2056498
rxcui: 2056502
spl id: 4e04737b-8d88-7c75-e063-6394a90a34c0
spl set id: 5d378add-f13d-40f2-99dc-0f2340ab44b7
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions70853a82-ba3b-4663-9f78-6791ca72ba9f2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8ac112c3-1e06-4fdb-a7af-2ee988de5b152026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack69fb5cd6-90ba-487d-a754-07c664a1fdd12026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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