Levothyroxine Sodium

Product NDC
82804-222
11-digit product format
828040222
Labeler code
82804
Product ID
82804-222_d010d2e7-ebbe-496a-a65c-5c7c95ceb9ca
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
100 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
82804-222-308280402223030 TABLET in 1 BOTTLE (82804-222-30) 30 tablet2025-08-19NoNoHistorical
82804-222-908280402229090 TABLET in 1 BOTTLE (82804-222-90) 90 tablet2025-04-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine SodiumProficient Rx LP2025-08-01HUMAN PRESCRIPTION DRUG LABEL2