FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
51655-484
11-digit product format
516550484
Labeler code
51655
Product ID
51655-484_4a1a0f52-62a3-c5b7-e063-6394a90a302a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA209713
Marketing category
ANDA
Marketing start
2020-11-23
Substance
LEVOTHYROXINE SODIUM
Active strength
.125 mg/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966224

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
51655-484-262026-01-29C16284748780-149896155-a53d-586f-e063-e6dba90add90These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
51655-484-522026-01-29C16284748780-149896155-a53d-586f-e063-e6dba90add90These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-484-26Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET903
51655-484-52Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-484LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240723_f317a597-4644-746a-e053-2995a90a807f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSNf317a597-4644-746a-e053-2995a90a807f3
966224levothyroxine sodium 0.125 MG Oral TabletSCDf317a597-4644-746a-e053-2995a90a807f3
966224levothyroxine sodium 125 MCG Oral TabletSYf317a597-4644-746a-e053-2995a90a807f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-484-265165504842690 TABLET in 1 BOTTLE, PLASTIC (51655-484-26) 90 tablet2020-11-23NoNoCurrent
51655-484-525165504845230 TABLET in 1 BOTTLE, PLASTIC (51655-484-52) 30 tablet2020-11-23NoNoCurrent