Levothyroxine Sodium

Product NDC
50436-9972
11-digit product format
504369972
Labeler code
50436
Product ID
50436-9972_e95b8511-d38e-4444-8e95-7afcd2129d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
NDA021210
Marketing category
NDA
Marketing start
2007-10-01
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
0 mg/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-9972-12020-01-31C16284748780-19d75b9d1-07c8-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9972-1Levothyroxine Sodium30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUM ANHYDROUSACTIVE INGREDIENT054I36CPMNLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9972LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20131201_ee5e8470-131f-4b3d-b99b-3528853689fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966270levothyroxine sodium 137 MCG Oral TabletPSNee5e8470-131f-4b3d-b99b-3528853689fa2
966270levothyroxine sodium 0.137 MG Oral TabletSCDee5e8470-131f-4b3d-b99b-3528853689fa2
966270levothyroxine sodium 137 MCG Oral TabletSYee5e8470-131f-4b3d-b99b-3528853689fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-9972-15043699720130 in 1 BOTTLEHistorical