FDA.reportPublic FDA data

Synthroid

Product NDC
68258-5948
11-digit product format
682585948
Labeler code
68258
Product ID
68258-5948_951444e0-5267-469a-9243-00952fc6b90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021402
Marketing category
NDA
Marketing start
2002-07-24
Marketing end
0000-00-00
Substance
LEVOTHYROXINE
Active strength
50 ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68258-5948-92019-11-27C16284748780-19855e2a2-45d2-60a7-e053-dbdaa90a05bdSYNTHROID® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-5948-9Synthroid90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINEACTIVE INGREDIENTQ51BO43MG4SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-5948SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20131003_2704cdb8-72a4-45cd-b718-d9723a284506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966221levothyroxine sodium 50 MCG Oral TabletPSN2704cdb8-72a4-45cd-b718-d9723a2845061
966247SYNTHROID 50 MCG Oral TabletPSN2704cdb8-72a4-45cd-b718-d9723a2845061
966247levothyroxine sodium 0.05 MG Oral Tablet [Synthroid]SBD2704cdb8-72a4-45cd-b718-d9723a2845061
966221levothyroxine sodium 0.05 MG Oral TabletSCD2704cdb8-72a4-45cd-b718-d9723a2845061
966221levothyroxine sodium 50 MCG Oral TabletSY2704cdb8-72a4-45cd-b718-d9723a2845061
966247Synthroid 0.05 MG Oral TabletSY2704cdb8-72a4-45cd-b718-d9723a2845061
966247Synthroid 50 MCG Oral TabletSY2704cdb8-72a4-45cd-b718-d9723a2845061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-5948-96825859480990 in 1 BOTTLE, PLASTICHistorical