levothyroxine sodium
- Product NDC
- 50090-4625
- Requested package NDC
- 50090-4625-0
- 11-digit product format
- 500904625
- Labeler code
- 50090
- Product ID
- 50090-4625_3e372ab2-62ee-46a7-be15-d127e2ae9196
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021116
- Marketing category
- NDA
- Marketing start
- 2019-05-07
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 150 ug/1
- Pharmacologic classes
- l-Thyroxine [EPC],Thyroxine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 50090-4625 | 50090-4625-0 | D | Discontinued by firm | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021116-001 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-002 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-003 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-004 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-005 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-006 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-007 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-008 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-009 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-010 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-011 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 |
| N021116-012 | THYRO-TABS | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2004-12-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021116-001 | AB1 |
| N021116-001 | AB2 |
| N021116-001 | AB3 |
| N021116-001 | AB4 |
| N021116-002 | AB1 |
| N021116-002 | AB2 |
| N021116-002 | AB3 |
| N021116-002 | AB4 |
| N021116-003 | AB1 |
| N021116-003 | AB2 |
| N021116-003 | AB3 |
| N021116-003 | AB4 |
| N021116-004 | AB1 |
| N021116-004 | AB2 |
| N021116-004 | AB3 |
| N021116-004 | AB4 |
| N021116-005 | AB1 |
| N021116-005 | AB2 |
| N021116-005 | AB3 |
| N021116-005 | AB4 |
| N021116-006 | AB1 |
| N021116-006 | AB2 |
| N021116-006 | AB3 |
| N021116-006 | AB4 |
| N021116-007 | AB1 |
| N021116-007 | AB2 |
| N021116-007 | AB3 |
| N021116-007 | AB4 |
| N021116-008 | AB1 |
| N021116-008 | AB2 |
| N021116-008 | AB3 |
| N021116-008 | AB4 |
| N021116-009 | AB1 |
| N021116-009 | AB2 |
| N021116-009 | AB3 |
| N021116-009 | AB4 |
| N021116-010 | AB1 |
| N021116-010 | AB2 |
| N021116-010 | AB3 |
| N021116-010 | AB4 |
| N021116-011 | AB1 |
| N021116-011 | AB2 |
| N021116-011 | AB3 |
| N021116-011 | AB4 |
| N021116-012 | AB1 |
| N021116-012 | AB2 |
| N021116-012 | AB3 |
| N021116-012 | AB4 |
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 | N021116-001 | THYRO-TABS | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-002 | THYRO-TABS | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-003 | THYRO-TABS | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-004 | THYRO-TABS | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-005 | THYRO-TABS | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-006 | THYRO-TABS | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-007 | THYRO-TABS | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-008 | THYRO-TABS | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-009 | THYRO-TABS | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-010 | THYRO-TABS | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-011 | THYRO-TABS | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-012 | THYRO-TABS | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2004-12-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-001 | THYRO-TABS | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-002 | THYRO-TABS | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-003 | THYRO-TABS | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-004 | THYRO-TABS | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-005 | THYRO-TABS | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-006 | THYRO-TABS | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-007 | THYRO-TABS | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-008 | THYRO-TABS | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-009 | THYRO-TABS | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-010 | THYRO-TABS | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-011 | THYRO-TABS | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021116-012 | THYRO-TABS | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2004-12-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-001 | THYRO-TABS | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-002 | THYRO-TABS | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-003 | THYRO-TABS | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-004 | THYRO-TABS | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-005 | THYRO-TABS | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-006 | THYRO-TABS | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-007 | THYRO-TABS | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-008 | THYRO-TABS | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-009 | THYRO-TABS | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-010 | THYRO-TABS | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-011 | THYRO-TABS | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021116-012 | THYRO-TABS | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2004-12-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021116-001 | THYRO-TABS | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021116-002 | THYRO-TABS | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021116-003 | THYRO-TABS | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021116-004 | THYRO-TABS | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AB1,AB2,AB3,AB4 | RLD | 2002-10-24 | 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 | N021116-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-001 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-001 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-001 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-002 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-002 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-002 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-003 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-003 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-003 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-004 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-004 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-004 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-005 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-005 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-005 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-006 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-006 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-006 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-007 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-007 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-007 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-008 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-008 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-008 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-009 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-009 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-009 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-010 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-010 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021116-010 | AB4 | 4 | 011fe1cb6892… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4625-0 | EA - Each | 50090-4625 | 9e58a728-0013-4634-8b7b-435b5cb7c69f | 1 | 2022-12-07 |
| 50090-4625-1 | EA - Each | 50090-4625 | 0dc1ca2d-aa67-42f1-9a95-3131661d7e9d | 1 | 2021-08-05 |
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 | Alvogen, Inc. | 4ddcaec1-a58f-340b-9bc1-bbe048b8c885 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 3b282e57-1009-4d2c-8ca2-9cca9f791937 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | eb53dc23-8337-497e-b466-192f905563ed | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 3519c765-2077-4f23-8644-a6242ddbf743 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | ac10b751-5195-4987-a841-400ae79730f0 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 645c52bb-c46e-426e-91d4-151aeac975a7 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | f2bed4e7-86e9-430e-80d9-7bd7cfcf9bf5 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 8f7dc71e-4a48-4ba5-945b-f340ff51636e | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 59a99739-2da5-46a7-8811-1169123bed9b | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 579b1935-77f5-4381-9cb0-e0130e4834e8 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 4e6dce46-cbf5-4353-9d0c-36b6f857197a | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | db5dd9d2-4f96-25d0-e053-2995a90af9dc | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | c9f4923e-5625-1d4f-e053-2a95a90aabc9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | db89c58f-9dd0-b6d6-e053-2a95a90ae2e7 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 48c29432-a36c-4787-a05f-8d25a0abcc37 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 00a4fc0b-7162-455e-8ed3-56efdbbe182e | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | c1b0fbad-5816-4152-ab59-05079e8c2148 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 9e3bffb9-f66e-4c73-befc-e60d769f6610 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 398a00d0-1247-4f6f-b4c1-dade399cc417 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4625-0 | 50090462500 | 30 TABLET in 1 BOTTLE (50090-4625-0) | 30 tablet | 2019-10-18 | 0000-00-00 | No | No | Current |