Levothyroxine sodium
- Product NDC
- 71335-2562
- Requested package NDC
- 71335-2562-2
- 11-digit product format
- 713352562
- Labeler code
- 71335
- Product ID
- 71335-2562_be577d92-7dbb-48c9-97fe-51ff0cdc44c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207588
- Marketing category
- ANDA
- Marketing start
- 2022-09-21
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 137 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207588-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | |
| A207588-012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207588-001 | AB1 |
| A207588-001 | AB2 |
| A207588-001 | AB3 |
| A207588-001 | AB4 |
| A207588-002 | AB1 |
| A207588-002 | AB2 |
| A207588-002 | AB3 |
| A207588-002 | AB4 |
| A207588-003 | AB1 |
| A207588-003 | AB2 |
| A207588-003 | AB3 |
| A207588-003 | AB4 |
| A207588-004 | AB1 |
| A207588-004 | AB2 |
| A207588-004 | AB3 |
| A207588-004 | AB4 |
| A207588-005 | AB1 |
| A207588-005 | AB2 |
| A207588-005 | AB3 |
| A207588-005 | AB4 |
| A207588-006 | AB1 |
| A207588-006 | AB2 |
| A207588-006 | AB3 |
| A207588-006 | AB4 |
| A207588-007 | AB1 |
| A207588-007 | AB2 |
| A207588-007 | AB3 |
| A207588-007 | AB4 |
| A207588-008 | AB1 |
| A207588-008 | AB2 |
| A207588-008 | AB3 |
| A207588-008 | AB4 |
| A207588-009 | AB1 |
| A207588-009 | AB2 |
| A207588-009 | AB3 |
| A207588-009 | AB4 |
| A207588-010 | AB1 |
| A207588-010 | AB2 |
| A207588-010 | AB3 |
| A207588-010 | AB4 |
| A207588-011 | AB1 |
| A207588-011 | AB2 |
| A207588-011 | AB3 |
| A207588-011 | AB4 |
| A207588-012 | AB1 |
| A207588-012 | AB2 |
| A207588-012 | AB3 |
| A207588-012 | 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 | A207588-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207588-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207588-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207588-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207588-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207588-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207588-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207588-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2022-05-10 | 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 | A207588-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-001 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-001 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-001 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-002 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-002 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-002 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-003 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-003 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-003 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-004 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-004 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-004 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-005 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-005 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-005 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-006 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-006 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-006 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-007 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-007 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-007 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-007 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-008 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-008 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-008 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-008 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-009 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-009 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-009 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-009 | AB4 | 4 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-010 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-010 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-010 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207588-010 | AB4 | 4 | 84e616aacf4f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM | 137 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 966270 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 702016f6-8507-471f-b833-3a582aef5d2e | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-2562-1 | Levothyroxine sodium | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 71335-2562-2 | Levothyroxine sodium | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 71335-2562-3 | Levothyroxine sodium | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 71335-2562-4 | Levothyroxine sodium | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 71335-2562-5 | Levothyroxine sodium | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-2562 | LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK] | 1 | Current NDC, 5 package rows | 20250130_702016f6-8507-471f-b833-3a582aef5d2e.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 | A-S Medication Solutions | 52a07ade-4098-477d-874e-dd692667041e | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 64aaeba7-1013-44a4-96fc-b876016897b3 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 65b266af-72a5-4409-ab55-bd14341135aa | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 9ff5ad8e-f28c-4322-be6e-072487878c12 | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 702016f6-8507-471f-b833-3a582aef5d2e | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 71335-2562-2 71335-2562 71335256202 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | a55e735f-a5b0-4b85-9fd7-3a4b6723a81b | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e1f77539-2156-4890-baca-8b13779c745c | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Teva Pharmaceuticals, Inc. | 60cadfd7-82b5-4207-97e1-1dd0655efb27 | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | 207588 ANDA207588 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966270 | levothyroxine sodium 137 MCG Oral Tablet | PSN | 702016f6-8507-471f-b833-3a582aef5d2e | 1 |
| 966270 | levothyroxine sodium 0.137 MG Oral Tablet | SCD | 702016f6-8507-471f-b833-3a582aef5d2e | 1 |
| 966270 | levothyroxine sodium 137 MCG Oral Tablet | SY | 702016f6-8507-471f-b833-3a582aef5d2e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-2562-2 | 71335256202 | 100 TABLET in 1 BOTTLE (71335-2562-2) | 100 tablet | 2025-01-28 | No | No | Current |