Levothyroxine Sodium
- Product NDC
- 0378-1800
- 11-digit product format
- 003781800
- Labeler code
- 0378
- Product ID
- 0378-1800_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076187
- Marketing category
- ANDA
- Marketing start
- 2002-11-01
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 25 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 |
|---|---|---|---|---|---|---|---|
| A076187-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | |
| A076187-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | RS | 2002-06-05 |
| A076187-012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2006-12-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076187-001 | AB1 |
| A076187-001 | AB2 |
| A076187-001 | AB3 |
| A076187-001 | AB4 |
| A076187-002 | AB1 |
| A076187-002 | AB2 |
| A076187-002 | AB3 |
| A076187-002 | AB4 |
| A076187-003 | AB1 |
| A076187-003 | AB2 |
| A076187-003 | AB3 |
| A076187-003 | AB4 |
| A076187-004 | AB1 |
| A076187-004 | AB2 |
| A076187-004 | AB3 |
| A076187-004 | AB4 |
| A076187-005 | AB1 |
| A076187-005 | AB2 |
| A076187-005 | AB3 |
| A076187-005 | AB4 |
| A076187-006 | AB1 |
| A076187-006 | AB2 |
| A076187-006 | AB3 |
| A076187-006 | AB4 |
| A076187-007 | AB1 |
| A076187-007 | AB2 |
| A076187-007 | AB3 |
| A076187-007 | AB4 |
| A076187-008 | AB1 |
| A076187-008 | AB2 |
| A076187-008 | AB3 |
| A076187-008 | AB4 |
| A076187-009 | AB1 |
| A076187-009 | AB2 |
| A076187-009 | AB3 |
| A076187-009 | AB4 |
| A076187-010 | AB1 |
| A076187-010 | AB2 |
| A076187-010 | AB3 |
| A076187-010 | AB4 |
| A076187-011 | AB1 |
| A076187-011 | AB2 |
| A076187-011 | AB3 |
| A076187-011 | AB4 |
| A076187-012 | AB1 |
| A076187-012 | AB2 |
| A076187-012 | AB3 |
| A076187-012 | 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 | A076187-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-008 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-009 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-010 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-011 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | RS | 2002-06-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-012 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2006-12-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-008 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-009 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-010 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-011 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | RS | 2002-06-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076187-012 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2006-12-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-008 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-009 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-010 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-011 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | RS | 2002-06-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076187-012 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2006-12-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076187-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076187-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076187-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076187-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3,AB4 | 2002-06-05 | 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 | A076187-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-001 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-001 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-001 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-002 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-002 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-002 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-003 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-003 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-003 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-004 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-004 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-004 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-005 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-005 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-005 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-006 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-006 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-006 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-007 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-007 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-007 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-008 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-008 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-008 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-009 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-009 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-009 | AB4 | 4 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-010 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-010 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076187-010 | AB4 | 4 | 011fe1cb6892… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM | 25 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 892246 | Internal RxNorm lookup |
| 892251 | Internal RxNorm lookup |
| 892255 | Internal RxNorm lookup |
| 966220 | Internal RxNorm lookup |
| 966221 | Internal RxNorm lookup |
| 966222 | Internal RxNorm lookup |
| 966224 | Internal RxNorm lookup |
| 966225 | Internal RxNorm lookup |
| 966248 | Internal RxNorm lookup |
| 966249 | Internal RxNorm lookup |
| 966253 | Internal RxNorm lookup |
| 966270 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 6a33ec05-2ae2-45e5-ab82-2d94b3303923 | Product name | 1 | 20190709 |
| 93355a10-1c44-4c92-a11d-7d995e0200d9 | Product name | 1 | 20190219 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-1800-10 | Levothyroxine Sodium | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 31 | |
| 0378-1800-77 | Levothyroxine Sodium | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-1800-01 | EA - Each | 0378-1800 | f01f5f09-2942-422d-9268-67302185dd2e | 1 | 2012-07-24 |
| 0378-1800-04 | EA - Each | 0378-1800 | 1c237712-a097-4d41-ac69-768f4d0e358b | 1 | 2020-09-14 |
| 0378-1800-10 | EA - Each | 0378-1800 | 3f9df775-17a5-4c7a-958c-df083df81a0d | 1 | 2012-07-24 |
| 0378-1800-77 | EA - Each | 0378-1800 | edb101ed-f6e7-4fa1-8c2e-596686e5d8fc | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
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 | Cardinal Health 107, LLC | 66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | db10e666-6204-56cc-e053-2995a90a9e08 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | fa15ac73-f4f6-7a6b-e053-6294a90a4f4e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Institutional Inc. | cd69c192-cd3f-47e6-b0a6-c536ffed5c4b | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Institutional Inc. | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Pharmaceuticals Inc. | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | 076187 ANDA076187 0378-1800 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966270 | levothyroxine sodium 137 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966249 | levothyroxine sodium 175 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892251 | levothyroxine sodium 200 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892255 | levothyroxine sodium 300 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | PSN | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966220 | levothyroxine sodium 0.025 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966222 | levothyroxine sodium 0.075 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966253 | levothyroxine sodium 0.088 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892246 | levothyroxine sodium 0.1 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966248 | levothyroxine sodium 0.112 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966224 | levothyroxine sodium 0.125 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966270 | levothyroxine sodium 0.137 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966225 | levothyroxine sodium 0.15 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966249 | levothyroxine sodium 0.175 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892251 | levothyroxine sodium 0.2 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892255 | levothyroxine sodium 0.3 MG Oral Tablet | SCD | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966270 | levothyroxine sodium 137 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966249 | levothyroxine sodium 175 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892251 | levothyroxine sodium 200 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 892255 | levothyroxine sodium 300 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | SY | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 31 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | PSN | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 966220 | levothyroxine sodium 0.025 MG Oral Tablet | SCD | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | SY | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | 58670656-1d49-46c1-ac43-d2e089a1698f | 16 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | PSN | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966220 | levothyroxine sodium 0.025 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966222 | levothyroxine sodium 0.075 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 892246 | levothyroxine sodium 0.1 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966224 | levothyroxine sodium 0.125 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966225 | levothyroxine sodium 0.15 MG Oral Tablet | SCD | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | SY | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 12 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | PSN | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966220 | levothyroxine sodium 0.025 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966222 | levothyroxine sodium 0.075 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966253 | levothyroxine sodium 0.088 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 892246 | levothyroxine sodium 0.1 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966248 | levothyroxine sodium 0.112 MG Oral Tablet | SCD | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | SY | 40840f67-7066-4bb6-85c1-73eb2618cd26 | 4 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4 | 2 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | b8fb4dcd-2531-40d3-bbfb-ccdc8ce327c4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-1800-04 | 00378180004 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1800-04) | 1000 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |
| 0378-1800-10 | 00378180010 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1800-10) | 1000 tablet | 2002-11-01 | 0000-00-00 | No | No | Current |
| 0378-1800-77 | 00378180077 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-1800-77) | 90 tablet | 2002-11-01 | 0000-00-00 | No | No | Current |