FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
72865-239
11-digit product format
728650239
Labeler code
72865
Product ID
72865-239_16376b6d-2936-4208-ab94-3e0969dce769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA215259
Marketing category
ANDA
Marketing start
2023-01-18
Substance
LEVOTHYROXINE SODIUM
Active strength
.088 mg/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 SODIUM.088 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui892246, 892251, 892255, 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
72865-239-10LEVOTHYROXINE SODIUM1000 in 1 BOTTLETABLET10001
72865-239-90LEVOTHYROXINE SODIUM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-239-10EA - Each72865-2393b77aab1-dc0e-4390-82f0-c05c5d7bc13312023-03-13
72865-239-90EA - Each72865-239c2b0144a-8ce9-4022-8c78-19fe98d7c50112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-239LEVOTHYROXINE SODIUM TABLET [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230209_51a27110-e787-409b-98ba-c6471d0ad5cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892246levothyroxine sodium 100 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966248levothyroxine sodium 112 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966224levothyroxine sodium 125 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966270levothyroxine sodium 137 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966225levothyroxine sodium 150 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966249levothyroxine sodium 175 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
892251levothyroxine sodium 200 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966220levothyroxine sodium 25 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
892255levothyroxine sodium 300 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966221levothyroxine sodium 50 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966222levothyroxine sodium 75 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966253levothyroxine sodium 88 MCG Oral TabletPSN51a27110-e787-409b-98ba-c6471d0ad5cf1
966220levothyroxine sodium 0.025 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966221levothyroxine sodium 0.05 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966222levothyroxine sodium 0.075 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966253levothyroxine sodium 0.088 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
892246levothyroxine sodium 0.1 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966248levothyroxine sodium 0.112 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966224levothyroxine sodium 0.125 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966270levothyroxine sodium 0.137 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966225levothyroxine sodium 0.15 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
966249levothyroxine sodium 0.175 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
892251levothyroxine sodium 0.2 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
892255levothyroxine sodium 0.3 MG Oral TabletSCD51a27110-e787-409b-98ba-c6471d0ad5cf1
892246levothyroxine sodium 100 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966248levothyroxine sodium 112 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966224levothyroxine sodium 125 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966270levothyroxine sodium 137 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966225levothyroxine sodium 150 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966249levothyroxine sodium 175 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
892251levothyroxine sodium 200 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966220levothyroxine sodium 25 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
892255levothyroxine sodium 300 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966221levothyroxine sodium 50 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966222levothyroxine sodium 75 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1
966253levothyroxine sodium 88 MCG Oral TabletSY51a27110-e787-409b-98ba-c6471d0ad5cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-239-10728650239101000 TABLET in 1 BOTTLE (72865-239-10) 1000 tablet2023-01-18NoNoCurrent
72865-239-907286502399090 TABLET in 1 BOTTLE (72865-239-90) 90 tablet2023-01-18NoNoCurrent