FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
51655-483
11-digit product format
516550483
Labeler code
51655
Product ID
51655-483_4a0072a5-e768-23cb-e063-6294a90ab11a
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
.088 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.088 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966253

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-483-26Levothyroxine Sodium90 in 1 BOTTLE, PLASTICTABLET903
51655-483-52Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-483LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240723_d9cb3417-e8cb-13f8-e053-2a95a90a294b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966253levothyroxine sodium 88 MCG Oral TabletPSNd9cb3417-e8cb-13f8-e053-2a95a90a294b3
966253levothyroxine sodium 0.088 MG Oral TabletSCDd9cb3417-e8cb-13f8-e053-2a95a90a294b3
966253levothyroxine sodium 88 MCG Oral TabletSYd9cb3417-e8cb-13f8-e053-2a95a90a294b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-483-265165504832690 TABLET in 1 BOTTLE, PLASTIC (51655-483-26) 90 tablet2020-11-23NoNoHistorical
51655-483-525165504835230 TABLET in 1 BOTTLE, PLASTIC (51655-483-52) 30 tablet2022-03-04NoNoHistorical