FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
51655-694
11-digit product format
516550694
Labeler code
51655
Product ID
51655-694_48722f04-d4a7-c58d-e063-6394a90a16f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
NDA021210
Marketing category
NDA
Marketing start
2021-04-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.15 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.15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966221, 966222, 966224, 966225, 966248, 966253, 966270

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
51655-694-522023-04-17C16284748780-1f386c649-cc06-0266-e053-dadaa90a7c1aLevothyroxine Sodium Tablets, USP
51655-694-522023-01-30C16284748780-1f386c649-cc06-0266-e053-dadaa90a7c1aLevothyroxine Sodium Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-694-52Levothyroxine Sodium30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-694LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS]3Current NDC, Legacy NDC, 1 package rows20230418_c968836a-f94c-4d13-e053-2995a90a8df5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 125 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 137 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 150 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966221levothyroxine sodium 50 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 75 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 88 MCG Oral TabletPSNc968836a-f94c-4d13-e053-2995a90a8df54
966221levothyroxine sodium 0.05 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 0.075 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 0.088 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966248levothyroxine sodium 0.112 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 0.125 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 0.137 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 0.15 MG Oral TabletSCDc968836a-f94c-4d13-e053-2995a90a8df54
966248levothyroxine sodium 112 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966224levothyroxine sodium 125 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966270levothyroxine sodium 137 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966225levothyroxine sodium 150 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966221levothyroxine sodium 50 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966222levothyroxine sodium 75 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54
966253levothyroxine sodium 88 MCG Oral TabletSYc968836a-f94c-4d13-e053-2995a90a8df54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-694-525165506945230 TABLET in 1 BOTTLE, PLASTIC (51655-694-52) 30 tablet2021-04-010000-00-00NoNoCurrent