Levothyroxine Sodium

Product NDC
0527-4961
11-digit product format
005274961
Labeler code
0527
Product ID
0527-4961_e91be09f-93f4-2893-e053-2995a90a6e40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levothyroxine sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
NDA021924
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-11-02
Marketing end
0000-00-00
Substance
LEVOTHYROXINE SODIUM
Active strength
175 ug/1
Pharmacologic classes
Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-4961DDiscontinued by firm2026-08-03
excluded packagepackage0527-49610527-4961-32DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0527-4961DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-49610527-4961-32DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 15 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021924-002TIROSINTLEVOTHYROXINE SODIUM0.025MGCAPSULE / ORALRLD2006-10-13
N021924-003TIROSINTLEVOTHYROXINE SODIUM0.05MGCAPSULE / ORALRLD2006-10-13
N021924-004TIROSINTLEVOTHYROXINE SODIUM0.075MGCAPSULE / ORALRLD2006-10-13
N021924-005TIROSINTLEVOTHYROXINE SODIUM0.1MGCAPSULE / ORALRLD2006-10-13
N021924-006TIROSINTLEVOTHYROXINE SODIUM0.125MGCAPSULE / ORALRLD2006-10-13
N021924-007TIROSINTLEVOTHYROXINE SODIUM0.15MGCAPSULE / ORALRLD2006-10-13
N021924-008TIROSINTLEVOTHYROXINE SODIUM0.112MGCAPSULE / ORALRLD2009-10-02
N021924-009TIROSINTLEVOTHYROXINE SODIUM0.137MGCAPSULE / ORALRLD2009-10-02
N021924-010TIROSINTLEVOTHYROXINE SODIUM0.088MGCAPSULE / ORALRLD2009-10-02
N021924-011TIROSINTLEVOTHYROXINE SODIUM0.175MGCAPSULE / ORALRLD2017-04-25
N021924-012TIROSINTLEVOTHYROXINE SODIUM0.2MGCAPSULE / ORALRLD, RS2017-04-25
N021924-013TIROSINTLEVOTHYROXINE SODIUM0.013MGCAPSULE / ORALRLD2007-08-01
N021924-014TIROSINTLEVOTHYROXINE SODIUM0.0375MGCAPSULE / ORALRLD2022-06-22
N021924-015TIROSINTLEVOTHYROXINE SODIUM0.044MGCAPSULE / ORALRLD2022-06-22
N021924-016TIROSINTLEVOTHYROXINE SODIUM0.0625MGCAPSULE / ORALRLD2022-06-22

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021924-002125645652044-09-26Drug product2026-03-20
N021924-003125645652044-09-26Drug product2026-03-20
N021924-004125645652044-09-26Drug product2026-03-20
N021924-005125645652044-09-26Drug product2026-03-20
N021924-006125645652044-09-26Drug product2026-03-20
N021924-007125645652044-09-26Drug product2026-03-20
N021924-008125645652044-09-26Drug product2026-03-20
N021924-009125645652044-09-26Drug product2026-03-20
N021924-010125645652044-09-26Drug product2026-03-20
N021924-011125645652044-09-26Drug product2026-03-20
N021924-012125645652044-09-26Drug product2026-03-20
N021924-013125645652044-09-26Drug product2026-03-20
N021924-014125645652044-09-26Drug product2026-03-20
N021924-015125645652044-09-26Drug product2026-03-20
N021924-016125645652044-09-26Drug product2026-03-20

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.

Product history page 1 of 15 · 576 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021924-002TIROSINT0.025MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-003TIROSINT0.05MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-004TIROSINT0.075MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-005TIROSINT0.1MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-006TIROSINT0.125MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-007TIROSINT0.15MGCAPSULE / ORALRLD2006-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-008TIROSINT0.112MGCAPSULE / ORALRLD2009-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-009TIROSINT0.137MGCAPSULE / ORALRLD2009-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-010TIROSINT0.088MGCAPSULE / ORALRLD2009-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-011TIROSINT0.175MGCAPSULE / ORALRLD2017-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-012TIROSINT0.2MGCAPSULE / ORALRLD, RS2017-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-013TIROSINT0.013MGCAPSULE / ORALRLD2007-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-014TIROSINT0.0375MGCAPSULE / ORALRLD2022-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-015TIROSINT0.044MGCAPSULE / ORALRLD2022-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021924-016TIROSINT0.0625MGCAPSULE / ORALRLD2022-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-002TIROSINT0.025MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-003TIROSINT0.05MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-004TIROSINT0.075MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-005TIROSINT0.1MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-006TIROSINT0.125MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-007TIROSINT0.15MGCAPSULE / ORALRLD2006-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-008TIROSINT0.112MGCAPSULE / ORALRLD2009-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-009TIROSINT0.137MGCAPSULE / ORALRLD2009-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-010TIROSINT0.088MGCAPSULE / ORALRLD2009-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-011TIROSINT0.175MGCAPSULE / ORALRLD2017-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-012TIROSINT0.2MGCAPSULE / ORALRLD, RS2017-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-013TIROSINT0.013MGCAPSULE / ORALRLD2007-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-014TIROSINT0.0375MGCAPSULE / ORALRLD2022-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-015TIROSINT0.044MGCAPSULE / ORALRLD2022-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021924-016TIROSINT0.0625MGCAPSULE / ORALRLD2022-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021924-002TIROSINT0.025MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-003TIROSINT0.05MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-004TIROSINT0.075MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-005TIROSINT0.1MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-006TIROSINT0.125MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-007TIROSINT0.15MGCAPSULE / ORALRLD2006-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-008TIROSINT0.112MGCAPSULE / ORALRLD2009-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-009TIROSINT0.137MGCAPSULE / ORALRLD2009-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-010TIROSINT0.088MGCAPSULE / ORALRLD2009-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021924-011TIROSINT0.175MGCAPSULE / ORALRLD2017-04-256a471c1ec25d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-12-28 21:50 UTC2021-12N021924-008AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021924-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021924-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021924-006AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021924-007AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021924-010AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021924-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021924-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021924-006AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021924-007AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021924-010AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021924-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021924-007AB18869cabd3fbd…
2023-05-13 08:27 UTC2023-05N021924-012AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021924-012AB13bdfa0b2c4d7…

Observed Orange Book patent history#

Patent history page 1 of 22 · 847 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00276914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00277233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00376914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00377233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00476914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00477233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00576914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00577233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00676914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00677233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00776914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00777233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00876914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00877233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00976914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-00977233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01076914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01077233902024-03-14Drug product2010-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01176914112024-03-14Drug product2019-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01177233902024-03-14Drug product2019-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01276914112024-03-14Drug product2019-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01277233902024-03-14Drug product2019-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01376914112024-03-14Drug product2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021924-01377233902024-03-14Drug product2010-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00276914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00277233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00376914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00377233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00476914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00477233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00576914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00577233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00676914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00677233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00776914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00777233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00876914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00877233902024-03-14Drug product2010-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00976914112024-03-14Drug product2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021924-00977233902024-03-14Drug product2010-05-272680178bc6a6…

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4961LEVOTHYROXINE SODIUM CAPSULE [LANNETT COMPANY, INC.]9Legacy NDC20240606_686ba2cf-7651-44de-9b4d-eeaaf2a0e364.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TirosintLEVOTHYROXINE SODIUMIBSA Pharma Inc.7a7ade79-0165-4e31-b84e-667416c00c7e2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021924
application number: NDA021924
Levothyroxine SodiumLEVOTHYROXINE SODIUMYARAL Pharma Inc.d28d7202-1278-0486-e053-2995a90af2862026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021924
application number: NDA021924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-4961-32005274961323 BLISTER PACK in 1 CARTON (0527-4961-32) > 10 CAPSULE in 1 BLISTER PACK3 blister pack2020-11-020000-00-00NoNoCurrent