Levothyroxine Sodium

Product NDC
82804-099
11-digit product format
828040099
Labeler code
82804
Product ID
82804-099_9e69af45-d5a3-4986-8ea5-dee9e59272d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-03
Substance
LEVOTHYROXINE SODIUM
Active strength
50 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-099-308280400993030 TABLET in 1 BOTTLE (82804-099-30) 30 tablet2024-04-25NoNoHistorical
82804-099-908280400999090 TABLET in 1 BOTTLE (82804-099-90) 90 tablet2024-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine SodiumProficient Rx LP2024-05-01HUMAN PRESCRIPTION DRUG LABEL2