FDA.reportPublic FDA data

Levothyroxine sodium

Product NDC
50090-7526
11-digit product format
500907526
Labeler code
50090
Product ID
50090-7526_67ace6ca-8292-4fb2-badd-9e1cceacc2c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207588
Marketing category
ANDA
Marketing start
2022-09-21
Substance
LEVOTHYROXINE SODIUM
Active strength
112 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 SODIUM112 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966248

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
50090-7526-0Levothyroxine sodium90 in 1 BOTTLETABLET901
50090-7526-1Levothyroxine sodium30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7526-0EA - Each50090-7526963f1a18-30af-4a84-8aaa-dc800e2df65012025-05-14
50090-7526-1EA - Each50090-7526d367d688-0e9a-479d-a6f1-97f1d639b94312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7526LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20250410_9ff5ad8e-f28c-4322-be6e-072487878c12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSN9ff5ad8e-f28c-4322-be6e-072487878c121
966248levothyroxine sodium 0.112 MG Oral TabletSCD9ff5ad8e-f28c-4322-be6e-072487878c121
966248levothyroxine sodium 112 MCG Oral TabletSY9ff5ad8e-f28c-4322-be6e-072487878c121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7526-05009075260090 TABLET in 1 BOTTLE (50090-7526-0) 90 tablet2025-04-02NoNoHistorical
50090-7526-15009075260130 TABLET in 1 BOTTLE (50090-7526-1) 30 tablet2025-04-02NoNoHistorical