Levothyroxine sodium

Product NDC
50090-6103
11-digit product format
500906103
Labeler code
50090
Product ID
50090-6103_36e5a909-10b8-42ed-8036-7460b052bdfa
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
2020-11-25
Substance
LEVOTHYROXINE SODIUM
Active strength
112 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 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
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
50090-6103-0Levothyroxine sodium90 in 1 BOTTLETABLET907
50090-6103-1Levothyroxine sodium30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6103-0EA - Each50090-6103d676dc51-8751-4fc2-a3a6-9312053ed6fb12022-11-07
50090-6103-1EA - Each50090-6103aac94e5c-aa2a-4797-a4ca-1af14bea5d3312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6103LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230525_36af0286-e447-4098-b3f2-772debd58667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966248levothyroxine sodium 112 MCG Oral TabletPSN36af0286-e447-4098-b3f2-772debd586677
966248levothyroxine sodium 0.112 MG Oral TabletSCD36af0286-e447-4098-b3f2-772debd586677
966248levothyroxine sodium 112 MCG Oral TabletSY36af0286-e447-4098-b3f2-772debd586677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6103-05009061030090 TABLET in 1 BOTTLE (50090-6103-0) 90 tablet2022-09-260000-00-00NoNoCurrent
50090-6103-15009061030130 TABLET in 1 BOTTLE (50090-6103-1) 30 tablet2022-09-260000-00-00NoNoCurrent