FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
72162-1458
11-digit product format
721621458
Labeler code
72162
Product ID
72162-1458_ef0397e5-d108-446b-84e5-ca8faecc28c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
25 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 SODIUM25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966220

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97c252d3-9bb8-4530-bb44-9824dc7cf556Product name620250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003Product name320240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8Product name520240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9fProduct name520240207
01383843-4069-43cf-aa76-dc17a6f9f8c4Product name220230123
978cca7d-a938-4791-8322-da48d90a63efProduct name120230113
65f86ba3-8816-4e12-899b-18290c8de551Product name220210614
f16ab90f-08c2-40be-a543-66d9827cd1f3Product name120210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1458-0levothyroxine sodium1000 in 1 BOTTLETABLET1000102
72162-1458-2levothyroxine sodium90 in 1 BOTTLETABLET90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1458-0EA - Each72162-145843e01f96-c68b-4a4c-9cb0-1702ec215c1e12025-05-14
72162-1458-2EA - Each72162-1458df89560a-3666-4588-b137-b4eae83555b312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1458LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20240718_3b282e57-1009-4d2c-8ca2-9cca9f791937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966220levothyroxine sodium 25 MCG Oral TabletPSN3b282e57-1009-4d2c-8ca2-9cca9f791937102
966220levothyroxine sodium 0.025 MG Oral TabletSCD3b282e57-1009-4d2c-8ca2-9cca9f791937102
966220levothyroxine sodium 25 MCG Oral TabletSY3b282e57-1009-4d2c-8ca2-9cca9f791937102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1458-0721621458001000 TABLET in 1 BOTTLE (72162-1458-0) 1000 tablet2019-05-07NoNoHistorical
72162-1458-27216214580290 TABLET in 1 BOTTLE (72162-1458-2) 90 tablet2024-07-16NoNoHistorical