FDA.reportPublic FDA data

LEVOTHYROXINE SODIUM

Product NDC
70771-1818
11-digit product format
707711818
Labeler code
70771
Product ID
70771-1818_09597387-9fda-47b3-8f60-51929fbfe54b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA217066
Marketing category
ANDA
Marketing start
2024-11-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217066-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24
A217066-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24
A217066-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217066-001AP
A217066-002AP
A217066-003AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217066-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24a50c72e98297…
2026-08-01 22:54:322026-06A217066-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24a50c72e98297…
2026-08-01 22:54:322026-06A217066-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2023-03-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217066-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A217066-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A217066-003AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMZydus Pharmaceuticals USA Inc.bf8a952c-f05b-4814-b55a-ed04be0152692025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217066
application number: ANDA217066

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

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
70771-1818-1LEVOTHYROXINE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
70771-1818-1LEVOTHYROXINE SODIUM5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1818LEVOTHYROXINE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 2 package rows20241102_f8a8dab3-3bd5-4238-b040-c42aa506ff73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSNf8a8dab3-3bd5-4238-b040-c42aa506ff732
1115267levothyroxine sodium 0.1 MG InjectionSCDf8a8dab3-3bd5-4238-b040-c42aa506ff732
1115267levothyroxine sodium 100 MCG InjectionSYf8a8dab3-3bd5-4238-b040-c42aa506ff732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1818-1707711818011 VIAL, SINGLE-DOSE in 1 CARTON (70771-1818-1) / 5 mL in 1 VIAL, SINGLE-DOSE2024-11-01NoNoCurrent