Levothyroxine Sodium
- Product NDC
- 0615-8573
- 11-digit product format
- 006158573
- Labeler code
- 0615
- Product ID
- 0615-8573_c721b631-8306-4573-98fb-26ebda5d1b95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- NDA021210
- Marketing category
- NDA
- Marketing start
- 2003-12-01
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- .025 mg/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021210-001 | UNITHROID | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-002 | UNITHROID | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-003 | UNITHROID | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-004 | UNITHROID | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-005 | UNITHROID | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-006 | UNITHROID | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-007 | UNITHROID | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-008 | UNITHROID | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-009 | UNITHROID | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-010 | UNITHROID | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 |
| N021210-011 | UNITHROID | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD, RS | 2000-08-21 |
| N021210-012 | UNITHROID | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2008-02-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021210-001 | AB1 |
| N021210-001 | AB2 |
| N021210-001 | AB3 |
| N021210-002 | AB1 |
| N021210-002 | AB2 |
| N021210-002 | AB3 |
| N021210-003 | AB1 |
| N021210-003 | AB2 |
| N021210-003 | AB3 |
| N021210-004 | AB1 |
| N021210-004 | AB2 |
| N021210-004 | AB3 |
| N021210-005 | AB1 |
| N021210-005 | AB2 |
| N021210-005 | AB3 |
| N021210-006 | AB1 |
| N021210-006 | AB2 |
| N021210-006 | AB3 |
| N021210-007 | AB1 |
| N021210-007 | AB2 |
| N021210-007 | AB3 |
| N021210-008 | AB1 |
| N021210-008 | AB2 |
| N021210-008 | AB3 |
| N021210-009 | AB1 |
| N021210-009 | AB2 |
| N021210-009 | AB3 |
| N021210-010 | AB1 |
| N021210-010 | AB2 |
| N021210-010 | AB3 |
| N021210-011 | AB1 |
| N021210-011 | AB2 |
| N021210-011 | AB3 |
| N021210-012 | AB1 |
| N021210-012 | AB2 |
| N021210-012 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021210-001 | UNITHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-002 | UNITHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-003 | UNITHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-004 | UNITHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-005 | UNITHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-006 | UNITHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-007 | UNITHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-008 | UNITHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-009 | UNITHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-010 | UNITHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-011 | UNITHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD, RS | 2000-08-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-012 | UNITHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2008-02-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-001 | UNITHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-002 | UNITHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-003 | UNITHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-004 | UNITHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-005 | UNITHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-006 | UNITHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-007 | UNITHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-008 | UNITHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-009 | UNITHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-010 | UNITHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-011 | UNITHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD, RS | 2000-08-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-012 | UNITHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2008-02-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-001 | UNITHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-002 | UNITHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-003 | UNITHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-004 | UNITHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-005 | UNITHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-006 | UNITHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-007 | UNITHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-008 | UNITHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-009 | UNITHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-010 | UNITHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-011 | UNITHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD, RS | 2000-08-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021210-012 | UNITHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2008-02-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021210-001 | UNITHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021210-002 | UNITHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021210-003 | UNITHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021210-004 | UNITHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | RLD | 2000-08-21 | 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 | N021210-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-001 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-001 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-002 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-002 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-003 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-003 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-004 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-004 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-005 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-005 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-006 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-006 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-007 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-007 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-008 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-008 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-009 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-009 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-010 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-010 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-011 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-011 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-011 | AB3 | 3 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-012 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-012 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021210-012 | AB3 | 3 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-001 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-001 | AB3 | 3 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021210-002 | AB1 | 1 | 31067a03dcf5… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM | .025 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 892246 | 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 |
|---|---|
| abe173cc-1579-43a5-b12d-a31958d0a539 | 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 |
|---|---|---|---|---|---|---|
| 0615-8573-05 | Levothyroxine Sodium | 15 in 1 BLISTER PACK | TABLET | 15 | 2 | |
| 0615-8573-14 | Levothyroxine Sodium | 14 in 1 BLISTER PACK | TABLET | 14 | 2 | |
| 0615-8573-39 | Levothyroxine Sodium | 30 in 1 BLISTER PACK | TABLET | 30 | 2 |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | abe173cc-1579-43a5-b12d-a31958d0a539 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 0615-8573 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | c968836a-f94c-4d13-e053-2995a90a8df5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Amneal Pharmaceuticals NY LLC | fca88c97-5cd4-4834-ba87-deb5bd637788 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 2f0657d5-3e5c-4249-bfaa-7f5ef1528672 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 97e28b00-9913-463f-9de2-08c828edbe67 | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 05ab038e-45fa-488e-a05e-12a2dd3564c1 | 2020-01-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | b81720f9-2836-4c1d-8691-0f6acef13316 | 2020-01-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 434075d5-a82b-4f17-85e6-4c1922663dbc | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 18c7c63a-642e-47fe-a8ee-12aaf652b2aa | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
| Unithroid | LEVOTHYROXINE SODIUM | Amneal Pharmaceuticals LLC | 07562e72-7eaa-4ce6-94f0-e08814787e50 | 2019-06-19 | Boxed warning, Warnings, Adverse reactions | 021210 NDA021210 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | PSN | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966220 | levothyroxine sodium 0.025 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966222 | levothyroxine sodium 0.075 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966253 | levothyroxine sodium 0.088 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 892246 | levothyroxine sodium 0.1 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966248 | levothyroxine sodium 0.112 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966224 | levothyroxine sodium 0.125 MG Oral Tablet | SCD | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 892246 | levothyroxine sodium 100 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966248 | levothyroxine sodium 112 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966220 | levothyroxine sodium 25 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | SY | abe173cc-1579-43a5-b12d-a31958d0a539 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0615-8573-05 | 00615857305 | 15 TABLET in 1 BLISTER PACK (0615-8573-05) | 15 tablet | 2026-04-14 | No | No | Current |
| 0615-8573-14 | 00615857314 | 14 TABLET in 1 BLISTER PACK (0615-8573-14) | 14 tablet | 2025-12-04 | No | No | Current |
| 0615-8573-39 | 00615857339 | 30 TABLET in 1 BLISTER PACK (0615-8573-39) | 30 tablet | 2025-12-04 | No | No | Current |