Levothyroxine Sodium

Product NDC
66794-201
11-digit product format
667940201
Labeler code
66794
Product ID
66794-201_3f9e1bbc-d3e2-c795-e063-6394a90aecdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care, Inc.
Application
ANDA206163
Marketing category
ANDA
Marketing start
2022-10-01
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
500 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 ANHYDROUS500 ug/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii054I36CPMN
Rxcui966219, 1115267

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
66794-201-02Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-USEINJECTION58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-201LEVOTHYROXINE SODIUM INJECTION [PIRAMAL CRITICAL CARE, INC.]7Current NDC, Legacy NDC, 1 package rows20241228_76139990-1355-cfb6-e053-2991aa0ace5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSN76139990-1355-cfb6-e053-2991aa0ace5b8
966219levothyroxine sodium 500 MCG InjectionPSN76139990-1355-cfb6-e053-2991aa0ace5b8
1115267levothyroxine sodium 0.1 MG InjectionSCD76139990-1355-cfb6-e053-2991aa0ace5b8
966219levothyroxine sodium 0.5 MG InjectionSCD76139990-1355-cfb6-e053-2991aa0ace5b8
1115267levothyroxine sodium 100 MCG InjectionSY76139990-1355-cfb6-e053-2991aa0ace5b8
966219levothyroxine sodium 500 MCG InjectionSY76139990-1355-cfb6-e053-2991aa0ace5b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-201-02667940201025 mL in 1 VIAL, SINGLE-USE (66794-201-02) 5 ml2022-10-010000-00-00NoNoCurrent