FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
82804-222
11-digit product format
828040222
Labeler code
82804
Product ID
82804-222_d010d2e7-ebbe-496a-a65c-5c7c95ceb9ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021342
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-08-03
Substance
LEVOTHYROXINE SODIUM
Active strength
100 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 SODIUM100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246

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
82804-222-30Levothyroxine Sodium30 in 1 BOTTLETABLET302
82804-222-90Levothyroxine Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-222-30EA - Each82804-2225488ef4e-6298-416c-a5f2-0980cdd2950812026-02-05
82804-222-90EA - Each82804-2224d1ea7b9-806a-45eb-869a-082c251ed04812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-222LEVOTHYROXINE SODIUM TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20250501_9e588c43-b9b5-478e-99f7-e197add3cd26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN9e588c43-b9b5-478e-99f7-e197add3cd262
892246levothyroxine sodium 0.1 MG Oral TabletSCD9e588c43-b9b5-478e-99f7-e197add3cd262
892246levothyroxine sodium 100 MCG Oral TabletSY9e588c43-b9b5-478e-99f7-e197add3cd262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-222-308280402223030 TABLET in 1 BOTTLE (82804-222-30) 30 tablet2025-08-19NoNoCurrent
82804-222-908280402229090 TABLET in 1 BOTTLE (82804-222-90) 90 tablet2025-04-24NoNoCurrent