levothyroxine sodium
- Product NDC
- 68071-2731
- 11-digit product format
- 680712731
- Labeler code
- 68071
- Product ID
- 68071-2731_dfd9ffe2-029b-7195-e053-2995a90a9b15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- NDA021116
- Marketing category
- NDA
- Marketing start
- 2019-05-07
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 88 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 68071-2731 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 68071-2731 | 68071-2731-9 | I | Inactivated by FDA | 2026-10-05 |
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 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2731-9 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2731-9 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2731-9 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2731-9 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021116-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-001 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-001 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-001 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-002 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-002 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-002 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-003 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-003 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-003 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-004 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-004 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-004 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-005 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-005 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-005 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-006 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-006 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-006 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-007 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-007 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-007 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-007 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-008 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-008 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-008 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-008 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-009 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-009 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-009 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-009 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-010 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-010 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-010 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021116-010 | AB4 | 4 | 84e616aacf4f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|
| 68071-2731-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b5ce-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2731-9 | levothyroxine sodium | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2731 | LEVOTHYROXINE SODIUM TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 1 package rows | 20220526_dfd9ef18-13c7-37b4-e053-2995a90af904.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 412fc3f4-d9e0-49c5-b042-a6010aea7e5e | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 021116 NDA021116 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | PSN | dfd9ef18-13c7-37b4-e053-2995a90af904 | 1 |
| 966253 | levothyroxine sodium 0.088 MG Oral Tablet | SCD | dfd9ef18-13c7-37b4-e053-2995a90af904 | 1 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | SY | dfd9ef18-13c7-37b4-e053-2995a90af904 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2731-9 | 68071273109 | 90 TABLET in 1 BOTTLE (68071-2731-9) | 90 tablet | 2022-05-25 | 0000-00-00 | No | No | Current |