FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
72603-663
11-digit product format
726030663
Labeler code
72603
Product ID
72603-663_4239467c-5eff-4c65-a966-483d318e1d41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA211417
Marketing category
ANDA
Marketing start
2025-04-08
Substance
LEVOTHYROXINE SODIUM
Active strength
88 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 SODIUM88 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270

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
72603-663-01LEVOTHYROXINE SODIUM1000 in 1 BOTTLETABLET10003
72603-663-02LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-663-01EA - Each72603-663510f4015-7ecd-4faf-98ce-3601bc470bbc12025-05-14
72603-663-02EA - Each72603-66388a9400d-8f39-433e-b327-cc0bd26baa2512026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-663LEVOTHYROXINE SODIUM TABLET [NORTHSTAR RXLLC]2Current NDC, 2 package rows20250423_58f4dc90-3648-49dc-a7e1-baf918a773b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966248levothyroxine sodium 112 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966224levothyroxine sodium 125 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966270levothyroxine sodium 137 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966225levothyroxine sodium 150 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966249levothyroxine sodium 175 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
892251levothyroxine sodium 200 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966220levothyroxine sodium 25 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966221levothyroxine sodium 50 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966222levothyroxine sodium 75 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966253levothyroxine sodium 88 MCG Oral TabletPSNcfab474d-3272-41fd-a8ec-762dd1a84fa63
966253levothyroxine sodium 88 MCG Oral TabletPSN58f4dc90-3648-49dc-a7e1-baf918a773b53
966220levothyroxine sodium 0.025 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966221levothyroxine sodium 0.05 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966222levothyroxine sodium 0.075 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966253levothyroxine sodium 0.088 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966253levothyroxine sodium 0.088 MG Oral TabletSCDcfab474d-3272-41fd-a8ec-762dd1a84fa63
892246levothyroxine sodium 0.1 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966248levothyroxine sodium 0.112 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966224levothyroxine sodium 0.125 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966270levothyroxine sodium 0.137 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966225levothyroxine sodium 0.15 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
966249levothyroxine sodium 0.175 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
892251levothyroxine sodium 0.2 MG Oral TabletSCD58f4dc90-3648-49dc-a7e1-baf918a773b53
892246levothyroxine sodium 100 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966248levothyroxine sodium 112 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966224levothyroxine sodium 125 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966270levothyroxine sodium 137 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966225levothyroxine sodium 150 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966249levothyroxine sodium 175 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
892251levothyroxine sodium 200 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966220levothyroxine sodium 25 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966221levothyroxine sodium 50 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966222levothyroxine sodium 75 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966253levothyroxine sodium 88 MCG Oral TabletSYcfab474d-3272-41fd-a8ec-762dd1a84fa63
966253levothyroxine sodium 88 MCG Oral TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966253levothyroxine sodium 88 MCG Oral TabletPSNb9a50170-ac0b-483e-9e85-1d03b12e4f7d1
966253levothyroxine sodium 0.088 MG Oral TabletSCDb9a50170-ac0b-483e-9e85-1d03b12e4f7d1
966253levothyroxine sodium 88 MCG Oral TabletSYb9a50170-ac0b-483e-9e85-1d03b12e4f7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-663-01726030663011000 TABLET in 1 BOTTLE (72603-663-01) 1000 tablet2025-04-08NoNoCurrent
72603-663-027260306630290 TABLET in 1 BOTTLE (72603-663-02) 90 tablet2026-03-31NoNoCurrent