Levothyroxine sodium
- Product NDC
- 43353-296
- 11-digit product format
- 433530296
- Labeler code
- 43353
- Product ID
- 43353-296_f867ba88-a009-4f0e-8792-d9e0d416117d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA021342
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2002-03-01
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 175 ug/1
- Pharmacologic classes
- l-Thyroxine [EPC],Thyroxine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 43353-296 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 43353-296 | 43353-296-60 | D | Discontinued by firm | 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 | 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 | 43353-296-60 | 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 | 43353-296-60 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021342-001 | LEVO-T | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-002 | LEVO-T | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-003 | LEVO-T | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-004 | LEVO-T | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-005 | LEVO-T | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-006 | LEVO-T | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-007 | LEVO-T | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-008 | LEVO-T | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-009 | LEVO-T | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-010 | LEVO-T | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-011 | LEVO-T | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-012 | LEVO-T | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021342-001 | AB1 |
| N021342-001 | AB2 |
| N021342-001 | AB3 |
| N021342-002 | AB1 |
| N021342-002 | AB2 |
| N021342-002 | AB3 |
| N021342-003 | AB1 |
| N021342-003 | AB2 |
| N021342-003 | AB3 |
| N021342-004 | AB1 |
| N021342-004 | AB2 |
| N021342-004 | AB3 |
| N021342-005 | AB1 |
| N021342-005 | AB2 |
| N021342-005 | AB3 |
| N021342-006 | AB1 |
| N021342-006 | AB2 |
| N021342-006 | AB3 |
| N021342-007 | AB1 |
| N021342-007 | AB2 |
| N021342-007 | AB3 |
| N021342-008 | AB1 |
| N021342-008 | AB2 |
| N021342-008 | AB3 |
| N021342-009 | AB1 |
| N021342-009 | AB2 |
| N021342-009 | AB3 |
| N021342-010 | AB1 |
| N021342-010 | AB2 |
| N021342-010 | AB3 |
| N021342-011 | AB1 |
| N021342-011 | AB2 |
| N021342-011 | AB3 |
| N021342-012 | AB1 |
| N021342-012 | AB2 |
| N021342-012 | AB3 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB3 | 3 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB2 | 2 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB3 | 3 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-002 | AB1 | 1 | caaa826d4ba7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-008 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-009 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-010 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-011 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-001 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-002 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-003 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-004 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-005 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-006 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-007 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-008 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-009 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-010 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-011 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-001 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-002 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-003 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-004 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-005 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-006 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-007 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-008 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-009 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-010 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-011 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 3f01610625f2… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-296-60 | EA - Each | 43353-296 | 3553581d-e20a-4945-ad6c-68fcbb1f3477 | 1 | 2017-11-06 |
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 |
|---|---|---|---|---|---|---|
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals,Inc. | b1b8c5a4-8132-24d2-e053-2995a90a59ec | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 56c633a9-3f64-46bd-b93f-afbff92b5559 | 2024-06-03 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | e1b322a6-9161-45b9-bf77-3c44502d5efd | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e486f83b-6cf0-4e7d-99ed-cfd19c4501e1 | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d6ce9798-7204-41df-9aeb-067000cb0895 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 59762069-5ea7-43d9-ba5b-8b250767b146 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | ca197216-83f1-470a-9313-d1b923924661 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 7ceed5ff-fd41-4ebd-ade7-e31b135231c1 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43353-296-60 | 43353029660 | 90 TABLET in 1 BOTTLE (43353-296-60) | 90 tablet | 2017-04-01 | 0000-00-00 | No | No | Current |