Levothyroxine Sodium

Product NDC
72266-261
11-digit product format
722660261
Labeler code
72266
Product ID
72266-261_33611328-03f9-d3f1-e063-6394a90ad483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOTHYROXINE SODIUM ANHYDROUS
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA216729
Marketing category
ANDA
Marketing start
2025-09-18
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM ANHYDROUS100 ug/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii054I36CPMN

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6a33ec05-2ae2-45e5-ab82-2d94b3303923Product name120190709
93355a10-1c44-4c92-a11d-7d995e0200d9Product name120190219
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-261-01Levothyroxine Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
72266-261-01Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-261-01EA - Each72266-26116081975-65ce-4372-96d5-38a74b2ab2aa12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSN3361138a-6e6f-e8df-e063-6294a90af2de1
1115267levothyroxine sodium 0.1 MG InjectionSCD3361138a-6e6f-e8df-e063-6294a90af2de1
1115267levothyroxine sodium 100 MCG InjectionSY3361138a-6e6f-e8df-e063-6294a90af2de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72266-261-01722660261011 VIAL, SINGLE-DOSE in 1 CARTON (72266-261-01) / 5 mL in 1 VIAL, SINGLE-DOSE2025-09-18NoNoCurrent