FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
0615-8597
11-digit product format
006158597
Labeler code
0615
Product ID
0615-8597_c721b631-8306-4573-98fb-26ebda5d1b95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
NDA021210
Marketing category
NDA
Marketing start
2003-12-01
Substance
LEVOTHYROXINE SODIUM
Active strength
.075 mg/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 SODIUM.075 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 966220, 966221, 966222, 966224, 966248, 966253

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
0615-8597-05Levothyroxine Sodium15 in 1 BLISTER PACKTABLET152
0615-8597-14Levothyroxine Sodium14 in 1 BLISTER PACKTABLET142
0615-8597-39Levothyroxine Sodium30 in 1 BLISTER PACKTABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966248levothyroxine sodium 112 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966224levothyroxine sodium 125 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966220levothyroxine sodium 25 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966221levothyroxine sodium 50 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966222levothyroxine sodium 75 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966253levothyroxine sodium 88 MCG Oral TabletPSNabe173cc-1579-43a5-b12d-a31958d0a5392
966220levothyroxine sodium 0.025 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
966221levothyroxine sodium 0.05 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
966222levothyroxine sodium 0.075 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
966253levothyroxine sodium 0.088 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
892246levothyroxine sodium 0.1 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
966248levothyroxine sodium 0.112 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
966224levothyroxine sodium 0.125 MG Oral TabletSCDabe173cc-1579-43a5-b12d-a31958d0a5392
892246levothyroxine sodium 100 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966248levothyroxine sodium 112 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966224levothyroxine sodium 125 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966220levothyroxine sodium 25 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966221levothyroxine sodium 50 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966222levothyroxine sodium 75 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392
966253levothyroxine sodium 88 MCG Oral TabletSYabe173cc-1579-43a5-b12d-a31958d0a5392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8597-050061585970515 TABLET in 1 BLISTER PACK (0615-8597-05) 15 tablet2026-01-08NoNoCurrent
0615-8597-140061585971414 TABLET in 1 BLISTER PACK (0615-8597-14) 14 tablet2026-01-08NoNoCurrent
0615-8597-390061585973930 TABLET in 1 BLISTER PACK (0615-8597-39) 30 tablet2026-01-08NoNoCurrent