Tirosint
- Product NDC
- 71858-0013
- Requested package NDC
- 71858-0013-1
- 11-digit product format
- 718580013
- Labeler code
- 71858
- Product ID
- 71858-0013_4ddc8742-bf50-baa5-e063-6294a90a56eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- IBSA Pharma Inc.
- Application
- NDA021924
- Marketing category
- NDA
- Marketing start
- 2023-03-01
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 44 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71858-0013 | 71858-0013-1 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| 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#
| 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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | N021924-008 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-006 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-007 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-010 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-006 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-007 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-010 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021924-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021924-007 | AB | 1 | 8869cabd3fbd… |
| 2023-05-13 08:27 UTC | 2023-05 | N021924-012 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021924-012 | AB | 1 | 3bdfa0b2c4d7… |
Observed Orange Book patent history#
| 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
- Tirosint
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM | 44 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 905451 | Internal RxNorm lookup |
| 905453 | Internal RxNorm lookup |
| 905455 | Internal RxNorm lookup |
| 905457 | Internal RxNorm lookup |
| 905458 | Internal RxNorm lookup |
| 905460 | Internal RxNorm lookup |
| 905462 | Internal RxNorm lookup |
| 905464 | 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 |
| 966415 | Internal RxNorm lookup |
| 966417 | Internal RxNorm lookup |
| 966420 | Internal RxNorm lookup |
| 966423 | Internal RxNorm lookup |
| 966426 | Internal RxNorm lookup |
| 966434 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7a7ade79-0165-4e31-b84e-667416c00c7e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 97c252d3-9bb8-4530-bb44-9824dc7cf556 | Product name | 6 | 20250729 |
| 6c43b71c-35e6-4db3-ba24-c6ef42ff7003 | Product name | 3 | 20240207 |
| 890fd4bf-1a80-42b7-be1b-2d0259d5f0c8 | Product name | 5 | 20240207 |
| c8ad26bf-af73-460b-b74e-1eff16cc4f9f | Product name | 5 | 20240207 |
| 01383843-4069-43cf-aa76-dc17a6f9f8c4 | Product name | 2 | 20230123 |
| 978cca7d-a938-4791-8322-da48d90a63ef | Product name | 1 | 20230113 |
| 65f86ba3-8816-4e12-899b-18290c8de551 | Product name | 2 | 20210614 |
| f16ab90f-08c2-40be-a543-66d9827cd1f3 | Product name | 1 | 20210601 |
| 6a33ec05-2ae2-45e5-ab82-2d94b3303923 | Product name | 1 | 20190709 |
| 93355a10-1c44-4c92-a11d-7d995e0200d9 | Product name | 1 | 20190219 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71858-0013-1 | Tirosint | 1 in 1 CARTON | CAPSULE | 1 | 13 | |
| 71858-0013-1 | Tirosint | 10 in 1 BLISTER PACK | CAPSULE | 10 | 13 | |
| 71858-0013-2 | Tirosint | 3 in 1 CARTON | CAPSULE | 3 | 13 | |
| 71858-0013-2 | Tirosint | 10 in 1 BLISTER PACK | CAPSULE | 10 | 13 | |
| 71858-0013-4 | Tirosint | 3 in 1 CARTON | CAPSULE | 3 | 13 | |
| 71858-0013-4 | Tirosint | 10 in 1 BLISTER PACK | CAPSULE | 10 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71858-0013-4 | EA - Each | 71858-0013 | 58362494-79b1-4a90-b650-1e2a20ec3a66 | 1 | 2023-04-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71858-0013 | TIROSINT (LEVOTHYROXINE SODIUM) CAPSULE [IBSA PHARMA INC.] | 11 | Current NDC, 6 package rows | 20241027_7a7ade79-0165-4e31-b84e-667416c00c7e.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tirosint | LEVOTHYROXINE SODIUM | IBSA Pharma Inc. | 7a7ade79-0165-4e31-b84e-667416c00c7e | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 021924 NDA021924 71858-0013-1 71858-0013 71858001301 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | YARAL Pharma Inc. | d28d7202-1278-0486-e053-2995a90af286 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 021924 NDA021924 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2630746 | levothyroxine sodium 0.0625 MG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966404 | levothyroxine sodium 100 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905451 | levothyroxine sodium 112 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966405 | levothyroxine sodium 125 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966412 | levothyroxine sodium 13 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905455 | levothyroxine sodium 137 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966413 | levothyroxine sodium 150 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923047 | levothyroxine sodium 175 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923050 | levothyroxine sodium 200 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966406 | levothyroxine sodium 25 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630738 | levothyroxine sodium 37.5 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630742 | levothyroxine sodium 44 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966407 | levothyroxine sodium 50 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905458 | levothyroxine sodium 75 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905462 | levothyroxine sodium 88 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966415 | Tirosint 100 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905453 | Tirosint 112 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966417 | Tirosint 125 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966434 | Tirosint 13 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905457 | Tirosint 137 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966420 | Tirosint 150 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923049 | Tirosint 175 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923052 | Tirosint 200 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966423 | Tirosint 25 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630740 | Tirosint 37.5 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630744 | Tirosint 44 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966426 | Tirosint 50 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630748 | Tirosint 62.5 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905460 | Tirosint 75 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905464 | Tirosint 88 MCG Oral Capsule | PSN | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966434 | levothyroxine sodium 0.013 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966423 | levothyroxine sodium 0.025 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630740 | levothyroxine sodium 0.0375 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630744 | levothyroxine sodium 0.044 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966426 | levothyroxine sodium 0.05 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630748 | levothyroxine sodium 0.0625 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905460 | levothyroxine sodium 0.075 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905464 | levothyroxine sodium 0.088 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966415 | levothyroxine sodium 0.1 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905453 | levothyroxine sodium 0.112 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966417 | levothyroxine sodium 0.125 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905457 | levothyroxine sodium 0.137 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966420 | levothyroxine sodium 0.15 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923049 | levothyroxine sodium 0.175 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923052 | levothyroxine sodium 0.2 MG Oral Capsule [Tirosint] | SBD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966412 | levothyroxine sodium 0.013 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966406 | levothyroxine sodium 0.025 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630738 | levothyroxine sodium 0.0375 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630742 | levothyroxine sodium 0.044 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966407 | levothyroxine sodium 0.05 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630746 | levothyroxine sodium 0.0625 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905458 | levothyroxine sodium 0.075 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905462 | levothyroxine sodium 0.088 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966404 | levothyroxine sodium 0.1 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905451 | levothyroxine sodium 0.112 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966405 | levothyroxine sodium 0.125 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905455 | levothyroxine sodium 0.137 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966413 | levothyroxine sodium 0.15 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923047 | levothyroxine sodium 0.175 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923050 | levothyroxine sodium 0.2 MG Oral Capsule | SCD | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966404 | levothyroxine sodium 100 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905451 | levothyroxine sodium 112 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966405 | levothyroxine sodium 125 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966412 | levothyroxine sodium 13 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905455 | levothyroxine sodium 137 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966413 | levothyroxine sodium 150 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923047 | levothyroxine sodium 175 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 1923050 | levothyroxine sodium 200 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966406 | levothyroxine sodium 25 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630738 | levothyroxine sodium 37.5 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630742 | levothyroxine sodium 44 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966407 | levothyroxine sodium 50 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630746 | levothyroxine sodium 62.5 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905458 | levothyroxine sodium 75 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 905462 | levothyroxine sodium 88 MCG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966434 | Tirosint 0.013 MG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966423 | Tirosint 0.025 MG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630740 | Tirosint 0.0375 MG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 2630744 | Tirosint 0.044 MG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
| 966426 | Tirosint 0.05 MG Oral Capsule | SY | 7a7ade79-0165-4e31-b84e-667416c00c7e | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71858-0013-1 | 71858001301 | 1 BLISTER PACK in 1 CARTON (71858-0013-1) / 10 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2023-03-01 | 2026-07-22 | Yes | No | Historical |