Levothyroxine Sodium

Product NDC
24201-002
11-digit product format
242010002
Labeler code
24201
Product ID
24201-002_563fecaf-128d-4f6b-81c8-715b4d90a261
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA214253
Marketing category
NDA
Marketing start
2022-11-15
Substance
LEVOTHYROXINE SODIUM
Active strength
100 ug/mL
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 SODIUM100 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9J765S329G
Rxcui2621123

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24201-002-01Levothyroxine Sodium2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
24201-002-01Levothyroxine Sodium1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24201-002LEVOTHYROXINE SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20250522_6279390b-ee61-4ef9-ac15-25537ca783c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2621123levothyroxine sodium 100 MCG in 1 ML InjectionPSN6279390b-ee61-4ef9-ac15-25537ca783c14
26211231 ML levothyroxine sodium 0.1 MG/ML InjectionSCD6279390b-ee61-4ef9-ac15-25537ca783c14
2621123levothyroxine sodium 100 MCG per 1 ML InjectionSY6279390b-ee61-4ef9-ac15-25537ca783c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24201-002-01242010002011 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE2022-11-150000-00-00NoNoCurrent