Levothyroxine sodium

Product NDC
82804-149
11-digit product format
828040149
Labeler code
82804
Product ID
82804-149_b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207588
Marketing category
ANDA
Marketing start
2022-09-21
Substance
LEVOTHYROXINE SODIUM
Active strength
50 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 SODIUM50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui966221

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
82804-149-30Levothyroxine sodium30 in 1 BOTTLETABLET301
82804-149-90Levothyroxine sodium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-149-30EA - Each82804-1494194fc00-4f70-4b0b-9557-c1b1a480dddb12024-12-10
82804-149-90EA - Each82804-14995bdf015-5a81-4a6d-b4c9-aea7c33653e012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-149LEVOTHYROXINE SODIUM TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20240927_b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966221levothyroxine sodium 50 MCG Oral TabletPSNb4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff81
966221levothyroxine sodium 0.05 MG Oral TabletSCDb4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff81
966221levothyroxine sodium 50 MCG Oral TabletSYb4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-149-308280401493030 TABLET in 1 BOTTLE (82804-149-30) 30 tablet2024-09-20NoNoCurrent
82804-149-908280401499090 TABLET in 1 BOTTLE (82804-149-90) 90 tablet2024-09-20NoNoCurrent