FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
83270-007
Requested package NDC
83270-007-01
11-digit product format
832700007
Labeler code
83270
Product ID
83270-007_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
200 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
A216729-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05
A216729-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05
A216729-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216729-001AP
A216729-002AP
A216729-003AP

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 22:54:322026-06A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…
2026-08-01 22:54:322026-06A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…
2026-08-01 22:54:322026-06A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216729-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A216729-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A216729-003AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSONESOURCE SPECIALTY PHARMA LIMITEDae9954a5-e196-449c-abea-ebe4afbee5172026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216729
application number: ANDA216729
ndc (package): 83270-007-01
ndc (product): 83270-007
ndc11 (package): 83270000701
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFosun Pharma USA Inc.3361138a-6e6f-e8df-e063-6294a90af2de2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216729
application number: ANDA216729

Additional Listing Data#

Finished product
Yes
Brand name base
Levothyroxine Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOTHYROXINE SODIUM ANHYDROUS200 ug/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
054I36CPMNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966219Internal RxNorm lookup
1115267Internal RxNorm lookup
1115269Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae9954a5-e196-449c-abea-ebe4afbee517Available on FDA.report

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
83270-007-01Levothyroxine Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
83270-007-01Levothyroxine Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52

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
83270-007-01832700007011 VIAL, SINGLE-DOSE in 1 CARTON (83270-007-01) / 5 mL in 1 VIAL, SINGLE-DOSE2025-09-30NoNoCurrent