FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
72603-661
11-digit product format
726030661
Labeler code
72603
Product ID
72603-661_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
50 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 SODIUM50 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
72603-661-01LEVOTHYROXINE SODIUM1000 in 1 BOTTLETABLET10003
72603-661-02LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-661-01EA - Each72603-6619969389b-e557-4c0e-bc07-b888b437db0712025-05-14
72603-661-02EA - Each72603-6615f4ab7c3-a471-48b6-8b46-53d5762002ed12026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-661LEVOTHYROXINE 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 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
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 TabletSY58f4dc90-3648-49dc-a7e1-baf918a773b53
966221levothyroxine sodium 50 MCG Oral TabletPSN70dddaf0-f495-495f-95de-36e9efa2e3731
966221levothyroxine sodium 50 MCG Oral TabletPSN510349d0-6397-7e2b-e063-6394a90a8a681
966221levothyroxine sodium 50 MCG Oral TabletPSN247f4d1d-6e65-4f81-a377-4dd88ae16dbb1
966221levothyroxine sodium 0.05 MG Oral TabletSCD510349d0-6397-7e2b-e063-6394a90a8a681
966221levothyroxine sodium 0.05 MG Oral TabletSCD70dddaf0-f495-495f-95de-36e9efa2e3731
966221levothyroxine sodium 0.05 MG Oral TabletSCD247f4d1d-6e65-4f81-a377-4dd88ae16dbb1
966221levothyroxine sodium 50 MCG Oral TabletSY510349d0-6397-7e2b-e063-6394a90a8a681
966221levothyroxine sodium 50 MCG Oral TabletSY247f4d1d-6e65-4f81-a377-4dd88ae16dbb1
966221levothyroxine sodium 50 MCG Oral TabletSY70dddaf0-f495-495f-95de-36e9efa2e3731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-661-01726030661011000 TABLET in 1 BOTTLE (72603-661-01) 1000 tablet2025-04-08NoNoCurrent
72603-661-027260306610290 TABLET in 1 BOTTLE (72603-661-02) 90 tablet2026-03-31NoNoCurrent