FDA.reportPublic FDA data

levothyroxine sodium

Product NDC
50090-4623
11-digit product format
500904623
Labeler code
50090
Product ID
50090-4623_23c48c36-172b-480d-a492-9e7571c76029
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
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
75 ug/1
Pharmacologic classes
l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-4623-02023-01-30C16284748780-1f386c64a-0414-0266-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
50090-4623-12023-01-30C16284748780-1f386c64a-0414-0266-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
50090-4623-0levothyroxine sodium30 in 1 BOTTLETABLET305
50090-4623-1levothyroxine sodium90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4623-0EA - Each50090-46235cde0694-8b4c-4c4e-8f3f-b69346dd8ebc12022-12-07
50090-4623-1EA - Each50090-46233eafed95-6259-41aa-8035-362d091329c612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4623LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_73219266-dbcd-4db3-8b1e-53d5a2bdc15d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966222levothyroxine sodium 75 MCG Oral TabletPSN73219266-dbcd-4db3-8b1e-53d5a2bdc15d5
966222levothyroxine sodium 0.075 MG Oral TabletSCD73219266-dbcd-4db3-8b1e-53d5a2bdc15d5
966222levothyroxine sodium 75 MCG Oral TabletSY73219266-dbcd-4db3-8b1e-53d5a2bdc15d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4623-05009046230030 TABLET in 1 BOTTLE (50090-4623-0) 30 tablet2019-10-180000-00-00NoNoCurrent
50090-4623-15009046230190 TABLET in 1 BOTTLE (50090-4623-1) 90 tablet2019-10-180000-00-00NoNoCurrent