Levothyroxine Sodium
- Product NDC
- 51655-095
- 11-digit product format
- 516550095
- Labeler code
- 51655
- Product ID
- 51655-095_c5f3891e-1d86-4dbe-940f-483494669c91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals
- Application
- NDA021342
- Marketing category
- NDA
- Marketing start
- 2014-12-17
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 0 mg/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
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 product | product | 51655-095 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 51655-095 | 51655-095-52 | D | Discontinued by firm | 2026-08-03 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-095-52 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-095-52 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-095-52 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-095-52 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-095-52 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-095-52 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-095-52 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-095-52 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-095-52 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 51655-095-52 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021342-001 | LEVO-T | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-002 | LEVO-T | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-003 | LEVO-T | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-004 | LEVO-T | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-005 | LEVO-T | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-006 | LEVO-T | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-007 | LEVO-T | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-008 | LEVO-T | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-009 | LEVO-T | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-010 | LEVO-T | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-011 | LEVO-T | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-012 | LEVO-T | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021342-001 | AB1 |
| N021342-001 | AB2 |
| N021342-001 | AB3 |
| N021342-002 | AB1 |
| N021342-002 | AB2 |
| N021342-002 | AB3 |
| N021342-003 | AB1 |
| N021342-003 | AB2 |
| N021342-003 | AB3 |
| N021342-004 | AB1 |
| N021342-004 | AB2 |
| N021342-004 | AB3 |
| N021342-005 | AB1 |
| N021342-005 | AB2 |
| N021342-005 | AB3 |
| N021342-006 | AB1 |
| N021342-006 | AB2 |
| N021342-006 | AB3 |
| N021342-007 | AB1 |
| N021342-007 | AB2 |
| N021342-007 | AB3 |
| N021342-008 | AB1 |
| N021342-008 | AB2 |
| N021342-008 | AB3 |
| N021342-009 | AB1 |
| N021342-009 | AB2 |
| N021342-009 | AB3 |
| N021342-010 | AB1 |
| N021342-010 | AB2 |
| N021342-010 | AB3 |
| N021342-011 | AB1 |
| N021342-011 | AB2 |
| N021342-011 | AB3 |
| N021342-012 | AB1 |
| N021342-012 | AB2 |
| N021342-012 | AB3 |
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 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021342-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-001 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-001 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | AB3 | 3 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | AB3 | 3 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-002 | AB1 | 1 | 31067a03dcf5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-008 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-009 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-010 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-011 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-001 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-002 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-003 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-004 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-005 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-006 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-007 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-008 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-009 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-010 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-011 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-001 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-002 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-003 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-004 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-005 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-006 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-007 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-008 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-009 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-010 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-011 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 3f01610625f2… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51655-095-52 | 2024-12-31 | C162847 | 48780-1 | 9d75b9d0-0235-f424-e053-dadaa90a57ce | Levothyroxine Sodium |
| 51655-095-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0235-f424-e053-dadaa90a57ce | Levothyroxine Sodium |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | ACTIVE INGREDIENT | 9J765S329G | LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS] | 1 | |
| LEVOTHYROXINE | ACTIVE MOIETY | Q51BO43MG4 | LEVOTHYROXINE SODIUM TABLET [NORTHWIND PHARMACEUTICALS] | 1 |
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 |
|---|---|---|---|---|---|---|
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 489ffba8-983e-478f-8f62-fe08bf3d0e0b | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5852d874-1ebc-49ff-b6c2-1dd513fca784 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | db5cba81-9ad5-42ad-ac9e-a967337630f2 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d9ccea69-109d-44cf-927b-4ff67652b6a0 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 50978a14-fd72-4c76-927f-667a1f097b87 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e293dd94-b523-47a2-8bed-e6d99945ee59 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 776c8dbc-ca34-40f9-9730-4aa59f644703 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5c1cf991-6177-499d-a9b8-63e5ca92eb79 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 3142571d-f253-45e7-adc1-6ca80d34cab1 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 513d066a-2fcc-44ad-80e1-23c339a56ac6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 1aaa327d-bb10-4815-8bd3-d8c9edc6c9db | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 64a663ac-ac02-4325-8f21-ee212e546121 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 4caf9040-5507-45a4-8f42-231aa925ab8d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 0210a600-747e-433a-8ba9-11692ecfb54a | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | ef7bc627-d37b-470e-b8f7-3c472c930d05 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d0beda93-9454-4846-b5c6-2a9113fb1765 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 0b9d21d8-9b49-4fd2-b516-b25bc6a6b671 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | caf7825d-f434-472f-94f3-217a41255562 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 73c3d459-dcbf-4458-8edd-2637275a96a1 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 4461bc9f-35db-4211-82ab-7671cf4dc14b | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |