Levothyroxine sodium

Product NDC
0781-5187
11-digit product format
007815187
Labeler code
0781
Product ID
0781-5187_b6216747-5ffb-6cd7-e053-2995a90a5ca0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc.
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2002-03-01
Marketing end
2021-12-31
Substance
LEVOTHYROXINE SODIUM
Active strength
150 ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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
0781-5187-01EA - Each0781-5187ccecd1e6-6bab-4e39-b78d-5c675d346bfe12012-07-24
0781-5187-10EA - Each0781-51876653e1a0-2ad1-4a63-987e-8cb5641bc05612012-07-24
0781-5187-92EA - Each0781-5187685e9d78-be0e-4a6e-98a4-9895f45781c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966225levothyroxine sodium 150 MCG Oral TabletPSNdec03393-0e77-4716-8db8-2ff996dd3f742
966225levothyroxine sodium 0.15 MG Oral TabletSCDdec03393-0e77-4716-8db8-2ff996dd3f742
966225levothyroxine sodium 150 MCG Oral TabletSYdec03393-0e77-4716-8db8-2ff996dd3f742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5187-10007815187101000 TABLET in 1 BOTTLE (0781-5187-10) 1000 tablet2002-03-012021-12-31NoNoCurrent
0781-5187-920078151879290 TABLET in 1 BOTTLE (0781-5187-92) 90 tablet2012-04-162021-12-31NoNoCurrent