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 8 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TirosintLEVOTHYROXINE SODIUMIBSA Pharma Inc.7a7ade79-0165-4e31-b84e-667416c00c7e2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021924
ndc (package): 71858-0025-2
ndc (package): 71858-0017-4
ndc (package): 71858-0050-1
ndc (package): 71858-0045-4
ndc (package): 71858-0040-2
ndc (package): 71858-0055-4
ndc (package): 71858-0005-4
ndc (package): 71858-0050-4
ndc (package): 71858-0060-4
ndc (package): 71858-0020-4
ndc (package): 71858-0055-2
ndc (package): 71858-0015-2
ndc (package): 71858-0010-2
ndc (package): 71858-0012-1
ndc (package): 71858-0035-1
ndc (package): 71858-0040-1
ndc (package): 71858-0025-4
ndc (package): 71858-0017-2
ndc (package): 71858-0015-1
ndc (package): 71858-0005-2
ndc (package): 71858-0030-2
ndc (package): 71858-0017-1
ndc (package): 71858-0012-2
ndc (package): 71858-0050-2
ndc (package): 71858-0005-1
ndc (package): 71858-0025-1
ndc (package): 71858-0012-4
ndc (package): 71858-0030-1
ndc (package): 71858-0060-1
ndc (package): 71858-0035-4
ndc (package): 71858-0013-4
ndc (package): 71858-0015-4
ndc (package): 71858-0055-1
ndc (package): 71858-0045-1
ndc (package): 71858-0035-2
ndc (package): 71858-0060-2
ndc (package): 71858-0020-2
ndc (package): 71858-0045-2
ndc (package): 71858-0030-4
ndc (package): 71858-0020-1
ndc (package): 71858-0013-1
ndc (package): 71858-0010-4
ndc (package): 71858-0040-4
ndc (package): 71858-0013-2
ndc (package): 71858-0010-1
ndc (product): 71858-0060
ndc (product): 71858-0035
ndc (product): 71858-0050
ndc (product): 71858-0013
ndc (product): 71858-0017
ndc (product): 71858-0015
ndc (product): 71858-0005
ndc (product): 71858-0020
ndc (product): 71858-0025
ndc (product): 71858-0045
ndc (product): 71858-0040
ndc (product): 71858-0010
ndc (product): 71858-0012
ndc (product): 71858-0030
ndc (product): 71858-0055
ndc11 (package): 71858001004
rxcui: 966407
rxcui: 905457
rxcui: 905464
rxcui: 966412
rxcui: 966423
rxcui: 1923049
rxcui: 966415
rxcui: 905453
rxcui: 966434
rxcui: 966417
rxcui: 1923047
rxcui: 966405
rxcui: 966413
rxcui: 1923050
rxcui: 966426
rxcui: 905458
rxcui: 905455
rxcui: 2630742
rxcui: 2630748
rxcui: 2630744
rxcui: 2630738
rxcui: 905460
rxcui: 966420
rxcui: 966406
rxcui: 2630746
rxcui: 905462
rxcui: 966404
rxcui: 2630740
rxcui: 1923052
rxcui: 905451
spl id: 4ddc8742-bf50-baa5-e063-6294a90a56eb
spl set id: 7a7ade79-0165-4e31-b84e-667416c00c7e
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMYARAL Pharma Inc.d28d7202-1278-0486-e053-2995a90af2862026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021924
rxcui: 966407
rxcui: 966412
rxcui: 1923047
rxcui: 966405
rxcui: 966413
rxcui: 1923050
rxcui: 905458
rxcui: 905455
rxcui: 966406
rxcui: 905462
rxcui: 966404
rxcui: 905451
unii: 9J765S329G
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7c8a6441-3c12-46ae-bb3b-a320d80045b62026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions008de8fd-150f-4022-8ccb-c8bfa94875c72026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions991399a4-ff94-44d0-b1ba-1f89e77594982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions87333260-fe57-4d99-886c-7c66cb0638982026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions52a07ade-4098-477d-874e-dd692667041e2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions67f46137-afc4-471b-a6c7-9c2aef92da5d2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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