Home NDC 24090-495 Tirosint
Product NDC 24090-495
11-digit product format 240900495
Labeler code 24090
Product ID 24090-495_a4458922-b538-42d6-b4d3-7942ee950f04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levothyroxine Sodium
Dosage form CAPSULE
Route ORAL
Labeler Akrimax Pharmaceuticals, LLC
Application NDA021924
Marketing category NDA
Marketing start 2010-04-01
Marketing end 0000-00-00
Substance LEVOTHYROXINE SODIUM
Active strength 100 ug/1
Pharmacologic classes l-Thyroxine [EPC],Thyroxine [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 65 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021924-002 TIROSINT LEVOTHYROXINE SODIUM 0.025MG CAPSULE / ORAL RLD 2006-10-13 N021924-003 TIROSINT LEVOTHYROXINE SODIUM 0.05MG CAPSULE / ORAL RLD 2006-10-13 N021924-004 TIROSINT LEVOTHYROXINE SODIUM 0.075MG CAPSULE / ORAL RLD 2006-10-13 N021924-005 TIROSINT LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL RLD 2006-10-13 N021924-006 TIROSINT LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL RLD 2006-10-13 N021924-007 TIROSINT LEVOTHYROXINE SODIUM 0.15MG CAPSULE / ORAL RLD 2006-10-13 N021924-008 TIROSINT LEVOTHYROXINE SODIUM 0.112MG CAPSULE / ORAL RLD 2009-10-02 N021924-009 TIROSINT LEVOTHYROXINE SODIUM 0.137MG CAPSULE / ORAL RLD 2009-10-02 N021924-010 TIROSINT LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL RLD 2009-10-02 N021924-011 TIROSINT LEVOTHYROXINE SODIUM 0.175MG CAPSULE / ORAL RLD 2017-04-25 N021924-012 TIROSINT LEVOTHYROXINE SODIUM 0.2MG CAPSULE / ORAL RLD, RS 2017-04-25 N021924-013 TIROSINT LEVOTHYROXINE SODIUM 0.013MG CAPSULE / ORAL RLD 2007-08-01 N021924-014 TIROSINT LEVOTHYROXINE SODIUM 0.0375MG CAPSULE / ORAL RLD 2022-06-22 N021924-015 TIROSINT LEVOTHYROXINE SODIUM 0.044MG CAPSULE / ORAL RLD 2022-06-22 N021924-016 TIROSINT LEVOTHYROXINE SODIUM 0.0625MG CAPSULE / ORAL RLD 2022-06-22
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021924-002 12564565 2044-09-26 Drug product 2026-03-20 N021924-003 12564565 2044-09-26 Drug product 2026-03-20 N021924-004 12564565 2044-09-26 Drug product 2026-03-20 N021924-005 12564565 2044-09-26 Drug product 2026-03-20 N021924-006 12564565 2044-09-26 Drug product 2026-03-20 N021924-007 12564565 2044-09-26 Drug product 2026-03-20 N021924-008 12564565 2044-09-26 Drug product 2026-03-20 N021924-009 12564565 2044-09-26 Drug product 2026-03-20 N021924-010 12564565 2044-09-26 Drug product 2026-03-20 N021924-011 12564565 2044-09-26 Drug product 2026-03-20 N021924-012 12564565 2044-09-26 Drug product 2026-03-20 N021924-013 12564565 2044-09-26 Drug product 2026-03-20 N021924-014 12564565 2044-09-26 Drug product 2026-03-20 N021924-015 12564565 2044-09-26 Drug product 2026-03-20 N021924-016 12564565 2044-09-26 Drug product 2026-03-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021924-002 TIROSINT 0.025MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-003 TIROSINT 0.05MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-004 TIROSINT 0.075MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-005 TIROSINT 0.1MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-006 TIROSINT 0.125MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-007 TIROSINT 0.15MG CAPSULE / ORAL RLD 2006-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-008 TIROSINT 0.112MG CAPSULE / ORAL RLD 2009-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-009 TIROSINT 0.137MG CAPSULE / ORAL RLD 2009-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-010 TIROSINT 0.088MG CAPSULE / ORAL RLD 2009-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-011 TIROSINT 0.175MG CAPSULE / ORAL RLD 2017-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-012 TIROSINT 0.2MG CAPSULE / ORAL RLD, RS 2017-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-013 TIROSINT 0.013MG CAPSULE / ORAL RLD 2007-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-014 TIROSINT 0.0375MG CAPSULE / ORAL RLD 2022-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-015 TIROSINT 0.044MG CAPSULE / ORAL RLD 2022-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021924-016 TIROSINT 0.0625MG CAPSULE / ORAL RLD 2022-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-002 TIROSINT 0.025MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-003 TIROSINT 0.05MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-004 TIROSINT 0.075MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-005 TIROSINT 0.1MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-006 TIROSINT 0.125MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-007 TIROSINT 0.15MG CAPSULE / ORAL RLD 2006-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-008 TIROSINT 0.112MG CAPSULE / ORAL RLD 2009-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-009 TIROSINT 0.137MG CAPSULE / ORAL RLD 2009-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-010 TIROSINT 0.088MG CAPSULE / ORAL RLD 2009-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-011 TIROSINT 0.175MG CAPSULE / ORAL RLD 2017-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-012 TIROSINT 0.2MG CAPSULE / ORAL RLD, RS 2017-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-013 TIROSINT 0.013MG CAPSULE / ORAL RLD 2007-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-014 TIROSINT 0.0375MG CAPSULE / ORAL RLD 2022-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-015 TIROSINT 0.044MG CAPSULE / ORAL RLD 2022-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021924-016 TIROSINT 0.0625MG CAPSULE / ORAL RLD 2022-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021924-002 TIROSINT 0.025MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-003 TIROSINT 0.05MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-004 TIROSINT 0.075MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-005 TIROSINT 0.1MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-006 TIROSINT 0.125MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-007 TIROSINT 0.15MG CAPSULE / ORAL RLD 2006-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-008 TIROSINT 0.112MG CAPSULE / ORAL RLD 2009-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-009 TIROSINT 0.137MG CAPSULE / ORAL RLD 2009-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-010 TIROSINT 0.088MG CAPSULE / ORAL RLD 2009-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021924-011 TIROSINT 0.175MG CAPSULE / ORAL RLD 2017-04-25 6a471c1ec25d…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 22 · 847 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-002 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-002 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-003 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-003 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-004 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-004 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-005 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-005 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-006 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-006 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-007 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-007 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-008 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-008 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-009 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-009 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-010 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-010 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-011 7691411 2024-03-14 Drug product 2019-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-011 7723390 2024-03-14 Drug product 2019-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-012 7691411 2024-03-14 Drug product 2019-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-012 7723390 2024-03-14 Drug product 2019-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-013 7691411 2024-03-14 Drug product 2016-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021924-013 7723390 2024-03-14 Drug product 2010-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-002 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-002 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-003 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-003 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-004 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-004 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-005 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-005 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-006 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-006 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-007 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-007 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-008 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-008 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-009 7691411 2024-03-14 Drug product 2016-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021924-009 7723390 2024-03-14 Drug product 2010-05-27 2680178bc6a6…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 24090-495-07 2020-09-15 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-84 2020-09-15 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-94 2020-09-15 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-99 2020-09-15 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-07 2020-01-31 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-84 2020-01-31 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-94 2020-01-31 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000 24090-495-99 2020-01-31 These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000
DailyMed Socrata Ingredients# 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.