Levothyroxine Sodium

Product NDC
83270-006
11-digit product format
832700006
Labeler code
83270
Product ID
83270-006_35b79b8a-71ee-374b-e063-6394a90a887a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA216729
Marketing category
ANDA
Marketing start
2025-08-15
Substance
LEVOTHYROXINE SODIUM ANHYDROUS
Active strength
100 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 ANHYDROUS100 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
83270-006-01Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52
83270-006-01Levothyroxine Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSNae9954a5-e196-449c-abea-ebe4afbee5172
1115269levothyroxine sodium 200 MCG InjectionPSNae9954a5-e196-449c-abea-ebe4afbee5172
966219levothyroxine sodium 500 MCG InjectionPSNae9954a5-e196-449c-abea-ebe4afbee5172
1115267levothyroxine sodium 0.1 MG InjectionSCDae9954a5-e196-449c-abea-ebe4afbee5172
1115269levothyroxine sodium 0.2 MG InjectionSCDae9954a5-e196-449c-abea-ebe4afbee5172
966219levothyroxine sodium 0.5 MG InjectionSCDae9954a5-e196-449c-abea-ebe4afbee5172
1115267levothyroxine sodium 100 MCG InjectionSYae9954a5-e196-449c-abea-ebe4afbee5172
1115269levothyroxine sodium 200 MCG InjectionSYae9954a5-e196-449c-abea-ebe4afbee5172
966219levothyroxine sodium 500 MCG InjectionSYae9954a5-e196-449c-abea-ebe4afbee5172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83270-006-01832700006011 VIAL, SINGLE-DOSE in 1 CARTON (83270-006-01) / 5 mL in 1 VIAL, SINGLE-DOSE2025-09-30NoNoCurrent