NDC 67046-0515-03 - 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
67046-0515
Requested NDC
67046-0515-03
Package NDCs from labels
67046-0515-3, 67046-0515-03
Manufacturer
Coupler LLC | Lupin Atlantis Holdings SA
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levothyroxine Sodium - Coupler LLC | Lupin Atlantis Holdings SACoupler LLC | Lupin Atlantis Holdings SA2026-05-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-0515-3Levothyroxine Sodium30 in 1 BLISTER PACKTABLET301

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 1 of 25 · 497 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.bc9385d0-5c67-4bde-94da-e621347e2cba2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966270
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.4c903249-69e9-4168-a9d1-22e6c2c1eb222026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966220
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6f25cbb3-0358-4778-b8f0-f76479a2dcc52026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892246
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.7fd988be-ab3d-406d-a55d-1e5a8a2101cc2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966224
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6108759a-783e-42ca-b078-6a3cd84ce9012026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.13e03769-9a4f-497f-9afa-95bf525090b32026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
rxcui: 966221
unii: 9J765S329G
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNorthStar RxLLC58f4dc90-3648-49dc-a7e1-baf918a773b52026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966248
rxcui: 892251
rxcui: 966222
rxcui: 966270
rxcui: 892246
rxcui: 966221
rxcui: 966224
rxcui: 966249
rxcui: 966220
rxcui: 966225
rxcui: 966253
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.597ea445-d926-adc6-e063-6394a90a64462026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
rxcui: 966222
unii: 9J765S329G
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
unii: 8MDF5V39QO
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f4c679-86cb-b97f-e063-6294a90ad5ef2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
rxcui: 966221
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f67831-4680-edbf-e063-6294a90a1d362026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
rxcui: 966270
unii: 9J765S329G

Reported adverse events (FAERS/openFDA)#

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