FDA.reportPublic FDA data

LEVOXYL

Product NDC
66336-601
11-digit product format
663360601
Labeler code
66336
Product ID
66336-601_ecb43b12-9ed4-45f7-8eb3-a03b985e912c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021301
Marketing category
NDA
Marketing start
2001-05-25
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
100 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
66336-601-902019-11-27C16284748780-19855e2a2-46ce-60a7-e053-dbdaa90a05bdLevoxyl ® (levothyroxine sodium tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-601-90LEVOXYL90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOXYL (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]2
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-601LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131106_ca3059aa-4d4c-4623-8b00-06b95ef0714a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNca3059aa-4d4c-4623-8b00-06b95ef0714a2
966221levothyroxine sodium 50 MCG Oral TabletPSNca3059aa-4d4c-4623-8b00-06b95ef0714a2
966283LEVOXYL 100 MCG Oral TabletPSNca3059aa-4d4c-4623-8b00-06b95ef0714a2
966164LEVOXYL 50 MCG Oral TabletPSNca3059aa-4d4c-4623-8b00-06b95ef0714a2
966164levothyroxine sodium 0.05 MG Oral Tablet [Levoxyl]SBDca3059aa-4d4c-4623-8b00-06b95ef0714a2
966283levothyroxine sodium 0.1 MG Oral Tablet [Levoxyl]SBDca3059aa-4d4c-4623-8b00-06b95ef0714a2
966221levothyroxine sodium 0.05 MG Oral TabletSCDca3059aa-4d4c-4623-8b00-06b95ef0714a2
892246levothyroxine sodium 0.1 MG Oral TabletSCDca3059aa-4d4c-4623-8b00-06b95ef0714a2
892246levothyroxine sodium 100 MCG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2
966221levothyroxine sodium 50 MCG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2
966164Levoxyl 0.05 MG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2
966283Levoxyl 0.1 MG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2
966283Levoxyl 100 MCG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2
966164Levoxyl 50 MCG Oral TabletSYca3059aa-4d4c-4623-8b00-06b95ef0714a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-601-906633606019090 in 1 BOTTLE, PLASTICHistorical