LEVOTHYROXINE SODIUM

Product NDC
68788-8811
11-digit product format
687888811
Labeler code
68788
Product ID
68788-8811_7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-01-20
Substance
LEVOTHYROXINE SODIUM
Active strength
175 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEVOTHYROXINE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM175 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 966222, 966249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8811-168788881101100 TABLET in 1 BOTTLE (68788-8811-1) 100 tablet2025-01-20NoNoHistorical
68788-8811-36878888110330 TABLET in 1 BOTTLE (68788-8811-3) 30 tablet2025-01-20NoNoHistorical
68788-8811-66878888110660 TABLET in 1 BOTTLE (68788-8811-6) 60 tablet2025-01-20NoNoHistorical
68788-8811-96878888110990 TABLET in 1 BOTTLE (68788-8811-9) 90 tablet2025-01-20NoNoHistorical