Levothyroxine Sodium

Product NDC
42023-202
11-digit product format
420230202
Labeler code
42023
Product ID
42023-202_7e79776a-ca4b-49a9-8bc8-131c425c0bb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ENDO USA, Inc.
Application
NDA202231
Marketing category
NDA
Marketing start
2011-06-24
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
200 ug/5mL
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 ANHYDROUS200 ug/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii054I36CPMN
Rxcui966219, 1115267, 1115269

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
42023-202-01Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,55
42023-202-01Levothyroxine Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-202LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]5Current NDC, Legacy NDC, 2 package rows20250509_9d815416-11c9-470e-a82f-89b0bf232e12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSN9d815416-11c9-470e-a82f-89b0bf232e125
1115269levothyroxine sodium 200 MCG InjectionPSN9d815416-11c9-470e-a82f-89b0bf232e125
966219levothyroxine sodium 500 MCG InjectionPSN9d815416-11c9-470e-a82f-89b0bf232e125
1115267levothyroxine sodium 0.1 MG InjectionSCD9d815416-11c9-470e-a82f-89b0bf232e125
1115269levothyroxine sodium 0.2 MG InjectionSCD9d815416-11c9-470e-a82f-89b0bf232e125
966219levothyroxine sodium 0.5 MG InjectionSCD9d815416-11c9-470e-a82f-89b0bf232e125
1115267levothyroxine sodium 100 MCG InjectionSY9d815416-11c9-470e-a82f-89b0bf232e125
1115269levothyroxine sodium 200 MCG InjectionSY9d815416-11c9-470e-a82f-89b0bf232e125
966219levothyroxine sodium 500 MCG InjectionSY9d815416-11c9-470e-a82f-89b0bf232e125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42023-202-01420230202011 VIAL, SINGLE-DOSE in 1 CARTON (42023-202-01) / 5 mL in 1 VIAL, SINGLE-DOSE2011-06-240000-00-00NoNoCurrent