FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
70710-1835
11-digit product format
707101835
Labeler code
70710
Product ID
70710-1835_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217066
Marketing category
ANDA
Marketing start
2024-11-01
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, 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
70710-1835-1LEVOTHYROXINE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
70710-1835-1LEVOTHYROXINE SODIUM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1835-1EA - Each70710-18350cbb5d84-2b2e-471f-b5c7-594351118ad412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1835LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20241102_bf8a952c-f05b-4814-b55a-ed04be015269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSNbf8a952c-f05b-4814-b55a-ed04be0152694
1115269levothyroxine sodium 200 MCG InjectionPSNbf8a952c-f05b-4814-b55a-ed04be0152694
966219levothyroxine sodium 500 MCG InjectionPSNbf8a952c-f05b-4814-b55a-ed04be0152694
1115267levothyroxine sodium 0.1 MG InjectionSCDbf8a952c-f05b-4814-b55a-ed04be0152694
1115269levothyroxine sodium 0.2 MG InjectionSCDbf8a952c-f05b-4814-b55a-ed04be0152694
966219levothyroxine sodium 0.5 MG InjectionSCDbf8a952c-f05b-4814-b55a-ed04be0152694
1115267levothyroxine sodium 100 MCG InjectionSYbf8a952c-f05b-4814-b55a-ed04be0152694
1115269levothyroxine sodium 200 MCG InjectionSYbf8a952c-f05b-4814-b55a-ed04be0152694
966219levothyroxine sodium 500 MCG InjectionSYbf8a952c-f05b-4814-b55a-ed04be0152694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1835-1707101835011 VIAL, SINGLE-DOSE in 1 CARTON (70710-1835-1) / 5 mL in 1 VIAL, SINGLE-DOSE2024-11-01NoNoCurrent