Levothyroxine sodium

Product NDC
50090-6116
11-digit product format
500906116
Labeler code
50090
Product ID
50090-6116_6be80fdb-db2e-4f69-a9f6-acc141bd36bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212399
Marketing category
ANDA
Marketing start
2020-12-10
Substance
LEVOTHYROXINE SODIUM
Active strength
25 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine sodium
Listing expiration
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6116-0Levothyroxine sodium30 in 1 BOTTLETABLET307
50090-6116-1Levothyroxine sodium90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6116-0EA - Each50090-6116236eb8e4-387a-4ec5-b8cf-376f00a4186b12022-11-07
50090-6116-1EA - Each50090-6116d7a9a914-b6b2-4c9c-86d1-905d8d083ba012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6116LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230427_e8142948-2bde-4f4b-931e-da43e91f2d59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966220levothyroxine sodium 25 MCG Oral TabletPSNe8142948-2bde-4f4b-931e-da43e91f2d597
966220levothyroxine sodium 0.025 MG Oral TabletSCDe8142948-2bde-4f4b-931e-da43e91f2d597
966220levothyroxine sodium 25 MCG Oral TabletSYe8142948-2bde-4f4b-931e-da43e91f2d597

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6116-05009061160030 TABLET in 1 BOTTLE (50090-6116-0) 30 tablet2022-09-300000-00-00NoNoCurrent
50090-6116-15009061160190 TABLET in 1 BOTTLE (50090-6116-1) 90 tablet2022-09-300000-00-00NoNoCurrent