Levothyroxine Sodium
- Product NDC
- 50090-6982
- 11-digit product format
- 500906982
- Labeler code
- 50090
- Product ID
- 50090-6982_48fee4f7-f275-45cf-8d4e-ad207cf91b23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209713
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- .125 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 |
|---|---|---|---|---|---|---|---|
| A209713-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | |
| A209713-012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209713-001 | AB1 |
| A209713-001 | AB2 |
| A209713-001 | AB3 |
| A209713-002 | AB1 |
| A209713-002 | AB2 |
| A209713-002 | AB3 |
| A209713-003 | AB1 |
| A209713-003 | AB2 |
| A209713-003 | AB3 |
| A209713-004 | AB1 |
| A209713-004 | AB2 |
| A209713-004 | AB3 |
| A209713-005 | AB1 |
| A209713-005 | AB2 |
| A209713-005 | AB3 |
| A209713-006 | AB1 |
| A209713-006 | AB2 |
| A209713-006 | AB3 |
| A209713-007 | AB1 |
| A209713-007 | AB2 |
| A209713-007 | AB3 |
| A209713-008 | AB1 |
| A209713-008 | AB2 |
| A209713-008 | AB3 |
| A209713-009 | AB1 |
| A209713-009 | AB2 |
| A209713-009 | AB3 |
| A209713-010 | AB1 |
| A209713-010 | AB2 |
| A209713-010 | AB3 |
| A209713-011 | AB1 |
| A209713-011 | AB2 |
| A209713-011 | AB3 |
| A209713-012 | AB1 |
| A209713-012 | AB2 |
| A209713-012 | 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 | A209713-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209713-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209713-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209713-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209713-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209713-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209713-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209713-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2019-01-18 | 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 | A209713-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-001 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-001 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-002 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-002 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-003 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-003 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-004 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-004 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-005 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-005 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-006 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-006 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-007 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-007 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-007 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-008 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-008 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-008 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-009 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-009 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-009 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-010 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-010 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-010 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-011 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-011 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-011 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-012 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-012 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209713-012 | AB3 | 3 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209713-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209713-001 | AB2 | 2 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209713-001 | AB3 | 3 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209713-002 | AB1 | 1 | caaa826d4ba7… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM | .125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 966224 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e2291336-1188-48f4-af52-d12ac892f80f | 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 |
|---|---|---|---|---|---|---|
| 50090-6982-0 | Levothyroxine Sodium | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 50090-6982-1 | Levothyroxine Sodium | 90 in 1 BOTTLE | TABLET | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6982-0 | EA - Each | 50090-6982 | 532ca8c0-7614-4d20-a2b6-8a6b21a30b36 | 1 | 2024-02-14 |
| 50090-6982-1 | EA - Each | 50090-6982 | 6f035a2b-177b-4987-a1a4-475d43b62ea0 | 1 | 2024-02-14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6982 | LEVOTHYROXINE SODIUM TABLET [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, 2 package rows | 20231229_e2291336-1188-48f4-af52-d12ac892f80f.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 | 3e77de84-6f59-40ac-a1a4-7bfe30387823 | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | 209713 ANDA209713 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | e2291336-1188-48f4-af52-d12ac892f80f | 9 |
| 966224 | levothyroxine sodium 0.125 MG Oral Tablet | SCD | e2291336-1188-48f4-af52-d12ac892f80f | 9 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | SY | e2291336-1188-48f4-af52-d12ac892f80f | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-6982-0 | 50090698200 | 30 TABLET in 1 BOTTLE (50090-6982-0) | 30 tablet | 2023-12-26 | No | No | Current |
| 50090-6982-1 | 50090698201 | 90 TABLET in 1 BOTTLE (50090-6982-1) | 90 tablet | 2023-12-26 | No | No | Current |