FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
0527-1351
11-digit product format
005271351
Labeler code
0527
Product ID
0527-1351_26a25b2e-75a8-4a96-8dad-e10ea25e6d72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
NDA021210
Marketing category
NDA
Marketing start
2003-12-01
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
0 mg/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1351-01EA - Each0527-13518395883f-4f81-4d58-9d0b-940bd557169812012-07-24
0527-1351-10EA - Each0527-13518c390e20-24ef-4417-b194-97af5db179c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUM ANHYDROUSACTIVE INGREDIENT054I36CPMNLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]4
Levothyroxine SodiumACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
D&C Red No. 27INACTIVE INGREDIENT2LRS185U6KLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
LactoseINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [MED-HEALTH PHARMA, LLC]3
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LEVOTHYROXINE SODIUM ANHYDROUSACTIVE INGREDIENT054I36CPMNLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
Levothyroxine SodiumACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
LevothyroxineACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
AcaciaINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Red No. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSNa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
966270levothyroxine sodium 137 MCG Oral TabletPSNa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
892251levothyroxine sodium 200 MCG Oral TabletPSNa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
966248levothyroxine sodium 0.112 MG Oral TabletSCDa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
966270levothyroxine sodium 0.137 MG Oral TabletSCDa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
892251levothyroxine sodium 0.2 MG Oral TabletSCDa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
966248levothyroxine sodium 112 MCG Oral TabletSYa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
966270levothyroxine sodium 137 MCG Oral TabletSYa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
892251levothyroxine sodium 200 MCG Oral TabletSYa3b269b2-6c33-4e5e-8880-5cc8f825f60c4
892246levothyroxine sodium 100 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966248levothyroxine sodium 112 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966224levothyroxine sodium 125 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966270levothyroxine sodium 137 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966225levothyroxine sodium 150 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966249levothyroxine sodium 175 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 200 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 200 MCG Oral TabletPSN6977f0ea-3343-4f99-bcc6-85acfeb697103
966220levothyroxine sodium 25 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892255levothyroxine sodium 300 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966221levothyroxine sodium 50 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966222levothyroxine sodium 75 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966253levothyroxine sodium 88 MCG Oral TabletPSNa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966220levothyroxine sodium 0.025 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966221levothyroxine sodium 0.05 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966222levothyroxine sodium 0.075 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966253levothyroxine sodium 0.088 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892246levothyroxine sodium 0.1 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966248levothyroxine sodium 0.112 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966224levothyroxine sodium 0.125 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966270levothyroxine sodium 0.137 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966225levothyroxine sodium 0.15 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966249levothyroxine sodium 0.175 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 0.2 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 0.2 MG Oral TabletSCD6977f0ea-3343-4f99-bcc6-85acfeb697103
892255levothyroxine sodium 0.3 MG Oral TabletSCDa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892246levothyroxine sodium 100 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966248levothyroxine sodium 112 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966224levothyroxine sodium 125 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966270levothyroxine sodium 137 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966225levothyroxine sodium 150 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966249levothyroxine sodium 175 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 200 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 200 MCG Oral TabletSY6977f0ea-3343-4f99-bcc6-85acfeb697103
966220levothyroxine sodium 25 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892255levothyroxine sodium 300 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966221levothyroxine sodium 50 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966222levothyroxine sodium 75 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
966253levothyroxine sodium 88 MCG Oral TabletSYa4e39e5c-59ee-4ba2-bf7f-62b5eae3afbc3
892251levothyroxine sodium 200 MCG Oral TabletPSN21a12ab0-43ac-4f9e-877d-a81d7463de172
892251levothyroxine sodium 200 MCG Oral TabletPSNbc30d803-45cd-4b72-9788-47d88a4a012c2
892251levothyroxine sodium 0.2 MG Oral TabletSCD21a12ab0-43ac-4f9e-877d-a81d7463de172
892251levothyroxine sodium 0.2 MG Oral TabletSCDbc30d803-45cd-4b72-9788-47d88a4a012c2
892251levothyroxine sodium 200 MCG Oral TabletSY21a12ab0-43ac-4f9e-877d-a81d7463de172
892251levothyroxine sodium 200 MCG Oral TabletSYbc30d803-45cd-4b72-9788-47d88a4a012c2
892246levothyroxine sodium 100 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 125 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 150 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 200 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 25 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 50 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 75 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 0.025 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 0.05 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 0.075 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892246levothyroxine sodium 0.1 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 0.125 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 0.15 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 0.2 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892246levothyroxine sodium 100 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 125 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 150 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 200 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 25 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 50 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 75 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51