Levothyroxine sodium

Product NDC
82804-168
11-digit product format
828040168
Labeler code
82804
Product ID
82804-168_678b11e4-a8a5-4b9a-a937-517c9320372f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-10
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-168-308280401683030 TABLET in 1 BOTTLE (82804-168-30) 30 tablet2024-12-09NoNoHistorical
82804-168-908280401689090 TABLET in 1 BOTTLE (82804-168-90) 90 tablet2024-12-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine sodiumProficient Rx LP2024-12-23HUMAN PRESCRIPTION DRUG LABEL2