FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
68788-9159
11-digit product format
687889159
Labeler code
68788
Product ID
68788-9159_b48b8776-184d-438c-8698-a1d8907cc704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-9159-32020-01-31C16284748780-19d75b9d0-194b-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP
68788-9159-92020-01-31C16284748780-19d75b9d0-194b-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9159-3Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET303
68788-9159-9Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9159LEVOTHYROXINE SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20170128_6977f0ea-3343-4f99-bcc6-85acfeb69710.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892251levothyroxine sodium 200 MCG Oral TabletPSN6977f0ea-3343-4f99-bcc6-85acfeb697103
892251levothyroxine sodium 0.2 MG Oral TabletSCD6977f0ea-3343-4f99-bcc6-85acfeb697103
892251levothyroxine sodium 200 MCG Oral TabletSY6977f0ea-3343-4f99-bcc6-85acfeb697103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9159-36878891590330 in 1 BOTTLE, PLASTICHistorical
68788-9159-96878891590990 in 1 BOTTLE, PLASTICHistorical