FDA.reportPublic FDA data

Synthroid

Product NDC
67544-884
11-digit product format
675440884
Labeler code
67544
Product ID
67544-884_81f2d4c7-c121-42a1-81a2-902b8eda11cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
NDA021402
Marketing category
NDA
Marketing start
2002-07-24
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
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
67544-884-302019-11-13C16284748780-197449f38-ce27-f6ea-e053-dbdaa90aa703SYNTHROID® (levothyroxine sodium tablets, USP)
67544-884-602019-11-13C16284748780-197449f38-ce27-f6ea-e053-dbdaa90aa703SYNTHROID® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-884-30Synthroid30 in 1 BOTTLE, PLASTICTABLET301
67544-884-60Synthroid90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-884-30EA - Each67544-884130cd21c-3d1f-41e2-bf47-e36eb855392e12012-07-24
67544-884-60EA - Each67544-884141ff066-f62f-4610-9dfb-aee7e6b575b012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1USYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-884SYNTHROID (LEVOTHYROXINE SODIUM) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1Legacy NDC, 2 package rows20120323_5be7ee95-a27e-409d-881f-927f42074033.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966248levothyroxine sodium 112 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966224levothyroxine sodium 125 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966225levothyroxine sodium 150 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966249levothyroxine sodium 175 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
892251levothyroxine sodium 200 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966220levothyroxine sodium 25 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966221levothyroxine sodium 50 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966222levothyroxine sodium 75 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966253levothyroxine sodium 88 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966250SYNTHROID 100 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966185SYNTHROID 112 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966191SYNTHROID 125 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966201SYNTHROID 150 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966205SYNTHROID 175 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966251SYNTHROID 200 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966158SYNTHROID 25 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966247SYNTHROID 50 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966171SYNTHROID 75 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966282SYNTHROID 88 MCG Oral TabletPSN5be7ee95-a27e-409d-881f-927f420740331
966158levothyroxine sodium 0.025 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966247levothyroxine sodium 0.05 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966171levothyroxine sodium 0.075 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966282levothyroxine sodium 0.088 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966250levothyroxine sodium 0.1 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966185levothyroxine sodium 0.112 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966191levothyroxine sodium 0.125 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966201levothyroxine sodium 0.15 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966205levothyroxine sodium 0.175 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966251levothyroxine sodium 0.2 MG Oral Tablet [Synthroid]SBD5be7ee95-a27e-409d-881f-927f420740331
966220levothyroxine sodium 0.025 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966221levothyroxine sodium 0.05 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966222levothyroxine sodium 0.075 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966253levothyroxine sodium 0.088 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
892246levothyroxine sodium 0.1 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966248levothyroxine sodium 0.112 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966224levothyroxine sodium 0.125 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966225levothyroxine sodium 0.15 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
966249levothyroxine sodium 0.175 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
892251levothyroxine sodium 0.2 MG Oral TabletSCD5be7ee95-a27e-409d-881f-927f420740331
892246levothyroxine sodium 100 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966248levothyroxine sodium 112 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966224levothyroxine sodium 125 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966225levothyroxine sodium 150 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966249levothyroxine sodium 175 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
892251levothyroxine sodium 200 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966220levothyroxine sodium 25 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966221levothyroxine sodium 50 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966222levothyroxine sodium 75 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966253levothyroxine sodium 88 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966158Synthroid 0.025 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966247Synthroid 0.05 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966171Synthroid 0.075 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966282Synthroid 0.088 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966250Synthroid 0.1 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966185Synthroid 0.112 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966191Synthroid 0.125 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966201Synthroid 0.15 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966205Synthroid 0.175 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966251Synthroid 0.2 MG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966250Synthroid 100 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966185Synthroid 112 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966191Synthroid 125 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966201Synthroid 150 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966205Synthroid 175 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966251Synthroid 200 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966158Synthroid 25 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966247Synthroid 50 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966171Synthroid 75 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331
966282Synthroid 88 MCG Oral TabletSY5be7ee95-a27e-409d-881f-927f420740331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-884-306754408843030 in 1 BOTTLE, PLASTICHistorical
67544-884-606754408846090 in 1 BOTTLE, PLASTICHistorical