levothyroxine sodium

Product NDC
71335-1465
11-digit product format
713351465
Labeler code
71335
Product ID
71335-1465_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
112 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-1465_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
levothyroxine sodium
Generic name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Marketing start
2019-05-07
Marketing category
NDA
Application number
NDA021116
Pharmacologic classes
Thyroxine [CS]; l-Thyroxine [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM112 ug/1

openFDA Harmonized Identifiers

FieldValues
Unii9J765S329G
Rxcui892246, 892251, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270
Spl Set Id9e3bffb9-f66e-4c73-befc-e60d769f6610
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9J765S329GLEVOTHYROXINE SODIUM6106-07-6LEVOTHYROXINE SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1465-17133514650130 TABLET in 1 BOTTLE (71335-1465-1) 30 tablet2019-05-070000-00-00NoNoCurrent
71335-1465-27133514650290 TABLET in 1 BOTTLE (71335-1465-2) 90 tablet2019-05-070000-00-00NoNoCurrent
71335-1465-37133514650360 TABLET in 1 BOTTLE (71335-1465-3) 60 tablet2019-05-070000-00-00NoNoCurrent
71335-1465-47133514650418 TABLET in 1 BOTTLE (71335-1465-4) 18 tablet2019-05-070000-00-00NoNoCurrent
71335-1465-571335146505100 TABLET in 1 BOTTLE (71335-1465-5) 100 tablet2019-05-070000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
levothyroxine sodiumBryant Ranch Prepack2025-07-29HUMAN PRESCRIPTION DRUG LABEL26