Levothyroxine Sodium

Product NDC
71335-1734
11-digit product format
713351734
Labeler code
71335
Product ID
71335-1734_4ece19ad-af1a-445f-8f91-10a733a24c32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-03
Substance
LEVOTHYROXINE SODIUM
Active strength
88 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
71335-1734_4ece19ad-af1a-445f-8f91-10a733a24c32
SPL ID
4ece19ad-af1a-445f-8f91-10a733a24c32
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Levothyroxine Sodium
Generic name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Marketing start
2020-08-03
Marketing category
NDA AUTHORIZED GENERIC
Application number
NDA021342
Pharmacologic classes
Thyroxine [CS]; l-Thyroxine [EPC]
Listing expiration
2027-12-31

openFDA Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM88 ug/1

openFDA Harmonized Identifiers

FieldValues
Unii9J765S329G
Rxcui966253
Spl Set Id64a663ac-ac02-4325-8f21-ee212e546121
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-1734-130 TABLET in 1 BOTTLE (71335-1734-1)2020-11-16No
71335-1734-290 TABLET in 1 BOTTLE (71335-1734-2)2020-11-17No
71335-1734-328 TABLET in 1 BOTTLE (71335-1734-3)2024-04-04No
71335-1734-4100 TABLET in 1 BOTTLE (71335-1734-4)2022-03-14No
71335-1734-560 TABLET in 1 BOTTLE (71335-1734-5)2024-04-04No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1734-17133517340130 TABLET in 1 BOTTLE (71335-1734-1) 30 tablet2020-11-16NoNoHistorical
71335-1734-27133517340290 TABLET in 1 BOTTLE (71335-1734-2) 90 tablet2020-11-17NoNoHistorical
71335-1734-37133517340328 TABLET in 1 BOTTLE (71335-1734-3) 28 tablet2024-04-04NoNoHistorical
71335-1734-471335173404100 TABLET in 1 BOTTLE (71335-1734-4) 100 tablet2022-03-14NoNoHistorical
71335-1734-57133517340560 TABLET in 1 BOTTLE (71335-1734-5) 60 tablet2024-04-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine SodiumBryant Ranch Prepack2026-05-14HUMAN PRESCRIPTION DRUG LABEL103