FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
33342-396
11-digit product format
333420396
Labeler code
33342
Product ID
33342-396_3a77ca51-7d8a-4755-aabc-3801cc772a10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211417
Marketing category
ANDA
Marketing start
2022-12-21
Substance
LEVOTHYROXINE SODIUM
Active strength
88 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEVOTHYROXINE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-396-10LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET903
33342-396-11LEVOTHYROXINE SODIUM100 in 1 BOTTLETABLET1003
33342-396-44LEVOTHYROXINE SODIUM1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-396LEVOTHYROXINE SODIUM TABLET [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 3 package rows20240323_b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966248levothyroxine sodium 112 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966224levothyroxine sodium 125 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966270levothyroxine sodium 137 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966225levothyroxine sodium 150 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966249levothyroxine sodium 175 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892251levothyroxine sodium 200 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966220levothyroxine sodium 25 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892255levothyroxine sodium 300 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966221levothyroxine sodium 50 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966222levothyroxine sodium 75 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966253levothyroxine sodium 88 MCG Oral TabletPSNb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966220levothyroxine sodium 0.025 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966221levothyroxine sodium 0.05 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966222levothyroxine sodium 0.075 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966253levothyroxine sodium 0.088 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892246levothyroxine sodium 0.1 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966248levothyroxine sodium 0.112 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966224levothyroxine sodium 0.125 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966270levothyroxine sodium 0.137 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966225levothyroxine sodium 0.15 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966249levothyroxine sodium 0.175 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892251levothyroxine sodium 0.2 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892255levothyroxine sodium 0.3 MG Oral TabletSCDb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892246levothyroxine sodium 100 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966248levothyroxine sodium 112 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966224levothyroxine sodium 125 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966270levothyroxine sodium 137 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966225levothyroxine sodium 150 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966249levothyroxine sodium 175 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892251levothyroxine sodium 200 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966220levothyroxine sodium 25 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
892255levothyroxine sodium 300 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966221levothyroxine sodium 50 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966222levothyroxine sodium 75 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966253levothyroxine sodium 88 MCG Oral TabletSYb8c20f76-3ee6-4b29-b77f-ed4ad1baaed93
966253levothyroxine sodium 88 MCG Oral TabletPSN8e11401b-f5c2-42ac-ba63-2e71b5626b7e1
966253levothyroxine sodium 88 MCG Oral TabletPSN6f4bc4be-17a7-4273-a8d9-a1ff036dea0e1
966253levothyroxine sodium 88 MCG Oral TabletPSN394b1006-c160-4668-8684-82d1c44812021
966253levothyroxine sodium 0.088 MG Oral TabletSCD8e11401b-f5c2-42ac-ba63-2e71b5626b7e1
966253levothyroxine sodium 0.088 MG Oral TabletSCD6f4bc4be-17a7-4273-a8d9-a1ff036dea0e1
966253levothyroxine sodium 0.088 MG Oral TabletSCD394b1006-c160-4668-8684-82d1c44812021
966253levothyroxine sodium 88 MCG Oral TabletSY8e11401b-f5c2-42ac-ba63-2e71b5626b7e1
966253levothyroxine sodium 88 MCG Oral TabletSY6f4bc4be-17a7-4273-a8d9-a1ff036dea0e1
966253levothyroxine sodium 88 MCG Oral TabletSY394b1006-c160-4668-8684-82d1c44812021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-396-103334203961090 TABLET in 1 BOTTLE (33342-396-10) 90 tablet2022-12-210000-00-00NoNoCurrent
33342-396-1133342039611100 TABLET in 1 BOTTLE (33342-396-11) 100 tablet2022-12-210000-00-00NoNoCurrent
33342-396-44333420396441000 TABLET in 1 BOTTLE (33342-396-44) 1000 tablet2023-01-24NoNoCurrent