FDA.reportPublic FDA data

NDC 82347-0010-04 - Levothyroxine Sodium

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
82347-0010
Requested NDC
82347-0010-04
Package NDCs from labels
82347-0010-4, 82347-0010-04
Manufacturer
YARAL 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
Levothyroxine Sodium - YARAL Pharma Inc.YARAL Pharma Inc.2026-03-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82347-0010-4Levothyroxine Sodium3 in 1 CARTONCAPSULE37
82347-0010-4Levothyroxine Sodium10 in 1 BLISTER PACKCAPSULE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82347-0010LEVOTHYROXINE SODIUM CAPSULE [YARAL PHARMA INC.]5Current NDC, Legacy NDC, 2 package rows20231128_d28d7202-1278-0486-e053-2995a90af286.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82347-0010-4EA - Each82347-0010534ec198-dcb4-494d-88c7-0888232eb7c612023-05-05

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
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
Levothyroxine SodiumLEVOTHYROXINE SODIUMYARAL Pharma Inc.d28d7202-1278-0486-e053-2995a90af2862026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021924
ndc (package): 82347-0035-4
ndc (package): 82347-0005-4
ndc (package): 82347-0060-4
ndc (package): 82347-0010-4
ndc (package): 82347-0040-4
ndc (package): 82347-0015-4
ndc (package): 82347-0050-4
ndc (package): 82347-0025-4
ndc (package): 82347-0030-4
ndc (package): 82347-0045-4
ndc (package): 82347-0055-4
ndc (package): 82347-0020-4
ndc (product): 82347-0040
ndc (product): 82347-0035
ndc (product): 82347-0025
ndc (product): 82347-0005
ndc (product): 82347-0030
ndc (product): 82347-0060
ndc (product): 82347-0015
ndc (product): 82347-0010
ndc (product): 82347-0055
ndc (product): 82347-0020
ndc (product): 82347-0045
ndc (product): 82347-0050
ndc11 (package): 82347001004
rxcui: 966407
rxcui: 966412
rxcui: 1923047
rxcui: 966405
rxcui: 966413
rxcui: 1923050
rxcui: 905458
rxcui: 905455
rxcui: 966406
rxcui: 905462
rxcui: 966404
rxcui: 905451
spl id: 4dde84bb-3bd3-6722-e063-6394a90a4c09
spl set id: d28d7202-1278-0486-e053-2995a90af286
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.