FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
50090-4799
11-digit product format
500904799
Labeler code
50090
Product ID
50090-4799_f2ee3fc5-4e2b-4b13-bd7c-7cbbf520ac1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021116
Marketing category
NDA
Marketing start
2019-05-07
Substance
LEVOTHYROXINE SODIUM
Active strength
125 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 SODIUM125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966224

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4799-02023-02-07C16284748780-1f386c64a-0e63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-12023-02-07C16284748780-1f386c64a-0e63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-02023-01-30C16284748780-1f386c64a-0e63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
50090-4799-12023-01-30C16284748780-1f386c64a-0e63-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4799-0levothyroxine sodium30 in 1 BOTTLETABLET3011
50090-4799-1levothyroxine sodium90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4799-0EA - Each50090-4799c86c571f-2481-4586-aabf-263107f5d18612026-03-17
50090-4799-1EA - Each50090-4799778fbd01-4696-43cc-b948-5356e5606e2812021-08-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966224levothyroxine sodium 125 MCG Oral TabletPSN8f7dc71e-4a48-4ba5-945b-f340ff51636e11
966224levothyroxine sodium 0.125 MG Oral TabletSCD8f7dc71e-4a48-4ba5-945b-f340ff51636e11
966224levothyroxine sodium 125 MCG Oral TabletSY8f7dc71e-4a48-4ba5-945b-f340ff51636e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4799-05009047990030 TABLET in 1 BOTTLE (50090-4799-0) 30 tablet2019-12-160000-00-00NoNoCurrent
50090-4799-15009047990190 TABLET in 1 BOTTLE (50090-4799-1) 90 tablet2019-12-160000-00-00NoNoCurrent