Levothyroxine sodium

Product NDC
67296-1908
11-digit product format
672961908
Labeler code
67296
Product ID
67296-1908_2c631b3a-4a1d-5890-e063-6394a90a6855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-11-25
Substance
LEVOTHYROXINE SODIUM
Active strength
137 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
67296-1908_2c631b3a-4a1d-5890-e063-6394a90a6855
SPL ID
2c631b3a-4a1d-5890-e063-6394a90a6855
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Levothyroxine sodium
Generic name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Marketing start
2020-11-25
Marketing category
ANDA
Application number
ANDA212399
Pharmacologic classes
Thyroxine [CS]; l-Thyroxine [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM137 ug/1

openFDA Harmonized Identifiers

FieldValues
Unii9J765S329G
Rxcui966270
Spl Set Idfcb196a2-31a6-437a-e053-6294a90a98ad
Manufacturer NameRedPharm Drug, Inc

openFDA Package Details

Package NDCDescriptionMarketing startSample
67296-1908-330 TABLET in 1 BOTTLE (67296-1908-3)2020-11-25No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1908-36729619080330 TABLET in 1 BOTTLE (67296-1908-3) 30 tablet2020-11-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine sodiumRedPharm Drug, Inc2025-01-23HUMAN PRESCRIPTION DRUG LABEL2