FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
33261-337
11-digit product format
332610337
Labeler code
33261
Product ID
33261-337_44cce19f-c8c1-4ec3-bc37-7d90521f0d99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA021342
Marketing category
NDA
Marketing start
2002-03-01
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
125 ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-337-302020-01-31C16284748780-19d75b9d0-fa2d-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP
33261-337-902020-01-31C16284748780-19d75b9d0-fa2d-f424-e053-dadaa90a57ceLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-337-30Levothyroxine sodium30 in 1 BOTTLE, PLASTICTABLET301
33261-337-90Levothyroxine sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-337-30EA - Each33261-337a91e2361-915a-477c-83a9-a1627da4c16b12015-10-02
33261-337-90EA - Each33261-337695e4df0-e8f1-49d5-9ecd-b7fb18590d1512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOTHYROXINE SODIUMACTIVE INGREDIENT9J765S329GLEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LEVOTHYROXINEACTIVE MOIETYQ51BO43MG4LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-337LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140110_69de922e-931e-4723-a91f-0cd774f008d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSN69de922e-931e-4723-a91f-0cd774f008d11
966224levothyroxine sodium 0.125 MG Oral TabletSCD69de922e-931e-4723-a91f-0cd774f008d11
966224levothyroxine sodium 125 MCG Oral TabletSY69de922e-931e-4723-a91f-0cd774f008d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-337-303326103373030 in 1 BOTTLE, PLASTICHistorical
33261-337-903326103379090 in 1 BOTTLE, PLASTICHistorical