Home NDC 82347-0010 Levothyroxine Sodium
Product NDC 82347-0010
11-digit product format 823470010
Labeler code 82347
Product ID 82347-0010_4dde84bb-3bd3-6722-e063-6394a90a4c09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levothyroxine sodium
Dosage form CAPSULE
Route ORAL
Labeler YARAL Pharma Inc.
Application NDA021924
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-03-01
Substance LEVOTHYROXINE SODIUM
Active strength 25 ug/1
Pharmacologic classes Thyroxine [CS], l-Thyroxine [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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…
Additional Listing Data#
Finished product Yes
Brand name base Levothyroxine Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOTHYROXINE SODIUM 25 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9J765S329G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905451 Internal RxNorm lookup 905455 Internal RxNorm lookup 905458 Internal RxNorm lookup 905462 Internal RxNorm lookup 966404 Internal RxNorm lookup 966405 Internal RxNorm lookup 966406 Internal RxNorm lookup 966407 Internal RxNorm lookup 966412 Internal RxNorm lookup 966413 Internal RxNorm lookup 1923047 Internal RxNorm lookup 1923050 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82347-0010-4 Levothyroxine Sodium 3 in 1 CARTON CAPSULE 3 7 82347-0010-4 Levothyroxine Sodium 10 in 1 BLISTER PACK CAPSULE 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82347-0010 LEVOTHYROXINE SODIUM CAPSULE [YARAL PHARMA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20231128_d28d7202-1278-0486-e053-2995a90af286.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82347-0010-4 82347001004 3 BLISTER PACK in 1 CARTON (82347-0010-4) / 10 CAPSULE in 1 BLISTER PACK 3 blister pack 2023-03-01 0000-00-00 No No Current