FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
47781-665
11-digit product format
477810665
Labeler code
47781
Product ID
47781-665_12e236b4-dc71-96ce-cdd3-7bede41b3f1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen, Inc.
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
175 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levothyroxine sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM175 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-665-10levothyroxine sodium1000 in 1 BOTTLETABLET10007
47781-665-90levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-665-10EA - Each47781-665087a0962-c877-4855-a8d4-7d25113914c312019-06-19
47781-665-90EA - Each47781-6655818ec66-3154-4ff0-b731-4ee88f0d643312019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-665LEVOTHYROXINE SODIUM TABLET [ALVOGEN, INC.]6Current NDC, Legacy NDC, 2 package rows20240317_4ddcaec1-a58f-340b-9bc1-bbe048b8c885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletPSN9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 0.025 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 0.05 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 0.075 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 0.088 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 0.1 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 0.112 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 0.125 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 0.137 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 0.15 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 0.175 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 0.2 MG Oral TabletSCD9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966248levothyroxine sodium 112 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966224levothyroxine sodium 125 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966270levothyroxine sodium 137 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966225levothyroxine sodium 150 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966249levothyroxine sodium 175 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892251levothyroxine sodium 200 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966220levothyroxine sodium 25 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966221levothyroxine sodium 50 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966222levothyroxine sodium 75 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
966253levothyroxine sodium 88 MCG Oral TabletSY9e3bffb9-f66e-4c73-befc-e60d769f661026
892246levothyroxine sodium 100 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966248levothyroxine sodium 112 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966224levothyroxine sodium 125 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966270levothyroxine sodium 137 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966225levothyroxine sodium 150 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletPSN3519c765-2077-4f23-8644-a6242ddbf7437
892251levothyroxine sodium 200 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 25 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892255levothyroxine sodium 300 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966221levothyroxine sodium 50 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 75 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966253levothyroxine sodium 88 MCG Oral TabletPSN4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 0.025 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966221levothyroxine sodium 0.05 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 0.075 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966253levothyroxine sodium 0.088 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892246levothyroxine sodium 0.1 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966248levothyroxine sodium 0.112 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966224levothyroxine sodium 0.125 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966270levothyroxine sodium 0.137 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966225levothyroxine sodium 0.15 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 0.175 MG Oral TabletSCD3519c765-2077-4f23-8644-a6242ddbf7437
966249levothyroxine sodium 0.175 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892251levothyroxine sodium 0.2 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892255levothyroxine sodium 0.3 MG Oral TabletSCD4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892246levothyroxine sodium 100 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966248levothyroxine sodium 112 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966224levothyroxine sodium 125 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966270levothyroxine sodium 137 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966225levothyroxine sodium 150 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletSY3519c765-2077-4f23-8644-a6242ddbf7437
892251levothyroxine sodium 200 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966220levothyroxine sodium 25 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
892255levothyroxine sodium 300 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966221levothyroxine sodium 50 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966222levothyroxine sodium 75 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966253levothyroxine sodium 88 MCG Oral TabletSY4ddcaec1-a58f-340b-9bc1-bbe048b8c8857
966249levothyroxine sodium 175 MCG Oral TabletPSNdb5dd9d2-4f96-25d0-e053-2995a90af9dc4
966249levothyroxine sodium 0.175 MG Oral TabletSCDdb5dd9d2-4f96-25d0-e053-2995a90af9dc4
966249levothyroxine sodium 175 MCG Oral TabletSYdb5dd9d2-4f96-25d0-e053-2995a90af9dc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-665-10477810665101000 TABLET in 1 BOTTLE (47781-665-10) 1000 tablet2019-05-070000-00-00NoNoCurrent
47781-665-904778106659090 TABLET in 1 BOTTLE (47781-665-90) 90 tablet2019-05-070000-00-00NoNoCurrent