levothyroxine sodium

Product NDC
71335-1447
11-digit product format
713351447
Labeler code
71335
Product ID
71335-1447_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
25 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
71335-1447_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
SPL ID
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

openFDA Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM25 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

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-1447-130 TABLET in 1 BOTTLE (71335-1447-1)2019-12-24No
71335-1447-290 TABLET in 1 BOTTLE (71335-1447-2)2019-12-24No
71335-1447-3100 TABLET in 1 BOTTLE (71335-1447-3)2019-12-24No
71335-1447-460 TABLET in 1 BOTTLE (71335-1447-4)2019-12-24No
71335-1447-528 TABLET in 1 BOTTLE (71335-1447-5)2019-12-24No
71335-1447-610 TABLET in 1 BOTTLE (71335-1447-6)2019-12-24No
71335-1447-71000 TABLET in 1 BOTTLE (71335-1447-7)2019-12-24No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1447-17133514470130 TABLET in 1 BOTTLE (71335-1447-1) 30 tablet2019-12-24NoNoHistorical
71335-1447-27133514470290 TABLET in 1 BOTTLE (71335-1447-2) 90 tablet2019-12-24NoNoHistorical
71335-1447-371335144703100 TABLET in 1 BOTTLE (71335-1447-3) 100 tablet2019-12-24NoNoHistorical
71335-1447-47133514470460 TABLET in 1 BOTTLE (71335-1447-4) 60 tablet2019-12-24NoNoHistorical
71335-1447-57133514470528 TABLET in 1 BOTTLE (71335-1447-5) 28 tablet2019-12-24NoNoHistorical
71335-1447-67133514470610 TABLET in 1 BOTTLE (71335-1447-6) 10 tablet2019-12-24NoNoHistorical
71335-1447-7713351447071000 TABLET in 1 BOTTLE (71335-1447-7) 1000 tablet2019-12-24NoNoHistorical

Related DailyMed Labels

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