Levothyroxine Sodium

Product NDC
82804-246
11-digit product format
828040246
Labeler code
82804
Product ID
82804-246_bcf10012-8920-4737-92f5-7401ee0c5894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209713
Marketing category
ANDA
Marketing start
2019-03-20
Substance
LEVOTHYROXINE SODIUM
Active strength
.125 mg/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
82804-246-308280402463030 TABLET in 1 BOTTLE (82804-246-30) 30 tablet2025-10-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine SodiumProficient Rx LP2025-10-01HUMAN PRESCRIPTION DRUG LABEL1