LEVOXYL
- Product NDC
- 66336-601
- 11-digit product format
- 663360601
- Labeler code
- 66336
- Product ID
- 66336-601_ecb43b12-9ed4-45f7-8eb3-a03b985e912c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA021301
- Marketing category
- NDA
- Marketing start
- 2001-05-25
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 100 ug/1
- Pharmacologic classes
- l-Thyroxine [EPC],Thyroxine [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 66336-601 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 66336-601 | 66336-601-90 | I | Inactivated by FDA | 2026-08-11 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 66336-601-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 66336-601-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 66336-601-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 66336-601-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 66336-601-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 66336-601-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 66336-601-90 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 66336-601-90 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66336-601-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 66336-601-90 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 66336-601-90 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66336-601-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66336-601-90 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66336-601-90 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66336-601-90 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66336-601-90 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66336-601-90 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66336-601-90 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66336-601-90 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66336-601-90 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66336-601-90 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66336-601-90 | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021301-001 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-002 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-003 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-004 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-005 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-006 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-007 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-008 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-009 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-010 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 |
| N021301-011 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD, RS | 2001-05-25 |
| N021301-012 | LEVOXYL | LEVOTHYROXINE SODIUM | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-05-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021301-001 | AB1 |
| N021301-001 | AB3 |
| N021301-002 | AB1 |
| N021301-002 | AB3 |
| N021301-003 | AB1 |
| N021301-003 | AB3 |
| N021301-004 | AB1 |
| N021301-004 | AB3 |
| N021301-005 | AB1 |
| N021301-005 | AB3 |
| N021301-006 | AB1 |
| N021301-006 | AB3 |
| N021301-007 | AB1 |
| N021301-007 | AB3 |
| N021301-008 | AB1 |
| N021301-008 | AB3 |
| N021301-009 | AB1 |
| N021301-009 | AB3 |
| N021301-010 | AB1 |
| N021301-010 | AB3 |
| N021301-011 | AB1 |
| N021301-011 | 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 | N021301-001 | LEVOXYL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-002 | LEVOXYL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-003 | LEVOXYL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-004 | LEVOXYL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-005 | LEVOXYL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-006 | LEVOXYL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-007 | LEVOXYL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-008 | LEVOXYL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-009 | LEVOXYL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-010 | LEVOXYL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-011 | LEVOXYL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD, RS | 2001-05-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-012 | LEVOXYL | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-05-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-001 | LEVOXYL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-002 | LEVOXYL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-003 | LEVOXYL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-004 | LEVOXYL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-005 | LEVOXYL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-006 | LEVOXYL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-007 | LEVOXYL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-008 | LEVOXYL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-009 | LEVOXYL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-010 | LEVOXYL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-011 | LEVOXYL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD, RS | 2001-05-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-012 | LEVOXYL | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-05-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-001 | LEVOXYL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-002 | LEVOXYL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-003 | LEVOXYL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-004 | LEVOXYL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-005 | LEVOXYL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-006 | LEVOXYL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-007 | LEVOXYL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-008 | LEVOXYL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-009 | LEVOXYL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-010 | LEVOXYL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-011 | LEVOXYL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD, RS | 2001-05-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021301-012 | LEVOXYL | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-05-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021301-001 | LEVOXYL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021301-002 | LEVOXYL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021301-003 | LEVOXYL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021301-004 | LEVOXYL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB3 | RLD | 2001-05-25 | 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 | N021301-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-001 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-002 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-003 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-004 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-005 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-006 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-007 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-008 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-009 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-010 | AB3 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-011 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021301-011 | AB3 | 2 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-001 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-002 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-003 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-004 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-005 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-006 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-007 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-007 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-008 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-008 | AB3 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-009 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021301-009 | AB3 | 2 | 31067a03dcf5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-001 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-001 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-001 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-002 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-002 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-002 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-003 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-003 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-003 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-004 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-004 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-004 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-005 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-005 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-005 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-006 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-006 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-006 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-007 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-007 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-007 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-008 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-008 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-008 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-009 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-009 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-009 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-010 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-010 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-010 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-011 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-011 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-011 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-012 | 6555581 | 2022-02-15 | 5c6f7cd8ea54… | |||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-012 | 7067148 | 2022-02-15 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021301-012 | 7101569 | 2023-10-02 | U-759 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021301-001 | 6555581 | 2022-02-15 | 5d02ea3f76ae… | |||
| 2022-04-08 23:34 UTC | 2022-04 | N021301-001 | 7067148 | 2022-02-15 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021301-001 | 7101569 | 2023-10-02 | U-759 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021301-002 | 6555581 | 2022-02-15 | 5d02ea3f76ae… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66336-601-90 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-46ce-60a7-e053-dbdaa90a05bd | Levoxyl ® (levothyroxine sodium tablets, USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66336-601-90 | LEVOXYL | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | ACTIVE INGREDIENT | 9J765S329G | LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| LEVOTHYROXINE | ACTIVE MOIETY | Q51BO43MG4 | LEVOXYL (LEVOTHYROXINE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| LEVOXYL | LEVOTHYROXINE SODIUM | Pfizer Laboratories Div Pfizer Inc | 758588c3-c63e-491b-0aa2-4f50d80cb174 | 2020-12-15 | Boxed warning, Warnings, Adverse reactions | 021301 NDA021301 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966283 | LEVOXYL 100 MCG Oral Tablet | PSN | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966164 | LEVOXYL 50 MCG Oral Tablet | PSN | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966164 | levothyroxine sodium 0.05 MG Oral Tablet [Levoxyl] | SBD | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966283 | levothyroxine sodium 0.1 MG Oral Tablet [Levoxyl] | SBD | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 892246 | levothyroxine sodium 0.1 MG Oral Tablet | SCD | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966164 | Levoxyl 0.05 MG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966283 | Levoxyl 0.1 MG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966283 | Levoxyl 100 MCG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
| 966164 | Levoxyl 50 MCG Oral Tablet | SY | ca3059aa-4d4c-4623-8b00-06b95ef0714a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66336-601-90 | 66336060190 | 90 in 1 BOTTLE, PLASTIC | Historical |