FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
21695-749
11-digit product format
216950749
Labeler code
21695
Product ID
21695-749_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
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
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
21695-749-302019-09-24C16284748780-1934fe258-4a7f-48b1-e053-8cdaa90a720aLevothyroxine Sodium Tablets, USP
21695-749-902019-09-24C16284748780-1934fe258-4a7f-48b1-e053-8cdaa90a720aLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-749-30Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET301
21695-749-90Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-749-30EA - Each21695-7492005a26c-ebca-41f4-8ce7-5fd62b8bd67c12012-07-24
21695-749-90EA - Each21695-7497f199e3f-9bcd-4bba-af46-caa6bef360e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Levothyroxine SodiumACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
LevothyroxineACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
AcaciaINACTIVE INGREDIENT5C5403N26OLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Red No. 40INACTIVE INGREDIENTWZB9127XOALEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJLEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-749LEVOTHYROXINE SODIUM TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20091230_dc827fec-2b59-416f-b203-252c03b686d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 125 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 150 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 200 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 25 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 50 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 75 MCG Oral TabletPSNdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 0.025 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 0.05 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 0.075 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892246levothyroxine sodium 0.1 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 0.125 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 0.15 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 0.2 MG Oral TabletSCDdc827fec-2b59-416f-b203-252c03b686d51
892246levothyroxine sodium 100 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966224levothyroxine sodium 125 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966225levothyroxine sodium 150 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
892251levothyroxine sodium 200 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966220levothyroxine sodium 25 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966221levothyroxine sodium 50 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51
966222levothyroxine sodium 75 MCG Oral TabletSYdc827fec-2b59-416f-b203-252c03b686d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-749-302169507493030 in 1 BOTTLE, PLASTICHistorical
21695-749-902169507499090 in 1 BOTTLE, PLASTICHistorical