Levothyroxine Sodium

Product NDC
71205-237
11-digit product format
712050237
Labeler code
71205
Product ID
71205-237_98d19b29-166e-42ae-ae3b-1ad981327766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021210
Marketing category
NDA
Marketing start
2007-10-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.137 mg/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
71205-237_98d19b29-166e-42ae-ae3b-1ad981327766
SPL ID
98d19b29-166e-42ae-ae3b-1ad981327766
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Levothyroxine Sodium
Generic name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Marketing start
2007-10-01
Marketing category
NDA
Application number
NDA021210
Pharmacologic classes
Thyroxine [CS]; l-Thyroxine [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
LEVOTHYROXINE SODIUM.137 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii9J765S329G
Rxcui966270
Spl Set Id18c7c63a-642e-47fe-a8ee-12aaf652b2aa
Manufacturer NameProficient Rx LP

openFDA Package Details

Package NDCDescriptionMarketing startSample
71205-237-3030 TABLET in 1 BOTTLE, PLASTIC (71205-237-30)2019-03-01No
71205-237-6060 TABLET in 1 BOTTLE, PLASTIC (71205-237-60)2019-03-01No
71205-237-9090 TABLET in 1 BOTTLE, PLASTIC (71205-237-90)2019-03-01No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-237-307120502373030 TABLET in 1 BOTTLE, PLASTIC (71205-237-30) 30 tablet2019-03-01NoNoHistorical
71205-237-607120502376060 TABLET in 1 BOTTLE, PLASTIC (71205-237-60) 60 tablet2019-03-01NoNoHistorical
71205-237-907120502379090 TABLET in 1 BOTTLE, PLASTIC (71205-237-90) 90 tablet2019-03-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Levothyroxine Sodium Tablets, USPProficient Rx LP2019-10-01HUMAN PRESCRIPTION DRUG LABEL2