FDA.reportPublic FDA data

Levothyroxine Sodium

Product NDC
25021-470
11-digit product format
250210470
Labeler code
25021
Product ID
25021-470_2662e418-ef9b-40be-abbd-db71401e3c20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levothyroxine Sodium Anhydrous
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA208749
Marketing category
ANDA
Marketing start
2024-01-01
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

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
A208749-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21
A208749-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21
A208749-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208749-001AP
A208749-002AP
A208749-003AP

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 22:54:322026-06A208749-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…
2026-08-01 22:54:322026-06A208749-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…
2026-08-01 22:54:322026-06A208749-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2018-12-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208749-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A208749-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A208749-003AP1a50c72e98297…

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 ANHYDROUSSagent Pharmaceuticalsf57e9b19-6f17-4520-80fc-511322cc56c92023-10-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208749
application number: ANDA208749
ndc (product): 25021-470
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSMAIA Pharmaceuticals, Inc.4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd2019-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208749
application number: ANDA208749

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 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
f57e9b19-6f17-4520-80fc-511322cc56c9Available 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
25021-470-10Levothyroxine Sodium5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,51
25021-470-10Levothyroxine Sodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-470-10EA - Each25021-4705f8b205a-e3d9-4f52-b318-bde3da6a81df12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-470LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20240111_f57e9b19-6f17-4520-80fc-511322cc56c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115267levothyroxine sodium 100 MCG InjectionPSNf57e9b19-6f17-4520-80fc-511322cc56c91
1115269levothyroxine sodium 200 MCG InjectionPSNf57e9b19-6f17-4520-80fc-511322cc56c91
966219levothyroxine sodium 500 MCG InjectionPSNf57e9b19-6f17-4520-80fc-511322cc56c91
1115267levothyroxine sodium 0.1 MG InjectionSCDf57e9b19-6f17-4520-80fc-511322cc56c91
1115269levothyroxine sodium 0.2 MG InjectionSCDf57e9b19-6f17-4520-80fc-511322cc56c91
966219levothyroxine sodium 0.5 MG InjectionSCDf57e9b19-6f17-4520-80fc-511322cc56c91
1115267levothyroxine sodium 100 MCG InjectionSYf57e9b19-6f17-4520-80fc-511322cc56c91
1115269levothyroxine sodium 200 MCG InjectionSYf57e9b19-6f17-4520-80fc-511322cc56c91
966219levothyroxine sodium 500 MCG InjectionSYf57e9b19-6f17-4520-80fc-511322cc56c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-470-10250210470101 VIAL in 1 CARTON (25021-470-10) / 5 mL in 1 VIAL1 vial2024-01-01NoNoCurrent