Levothyroxine Sodium
- Product NDC
- 71335-3116
- 11-digit product format
- 713353116
- Labeler code
- 71335
- Product ID
- 71335-3116_03c8c731-bb36-40e0-bd9d-8a90c31c3301
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209713
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- .15 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | 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 | c2088c7a36db… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209713-001 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-001 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-001 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-002 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-002 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-002 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-003 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-003 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-003 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-004 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-004 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-004 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-005 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-005 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-005 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-006 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-006 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-006 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-007 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-007 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-007 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-008 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-008 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-008 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-009 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-009 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-009 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-010 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-010 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-010 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-011 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-011 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-011 | AB3 | 3 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-012 | AB1 | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-012 | AB2 | 2 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A209713-012 | AB3 | 3 | c2088c7a36db… |
| 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… |
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 | .15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9J765S329G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 966225 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ecaa38f-8a6f-4536-8033-251d2c52ae64 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-3116-1 | Levothyroxine Sodium | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 71335-3116-2 | Levothyroxine Sodium | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 71335-3116-3 | Levothyroxine Sodium | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 71335-3116-4 | Levothyroxine Sodium | 60 in 1 BOTTLE | TABLET | 60 | 1 |
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 |
|---|---|---|---|---|
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | PSN | 2ecaa38f-8a6f-4536-8033-251d2c52ae64 | 1 |
| 966225 | levothyroxine sodium 0.15 MG Oral Tablet | SCD | 2ecaa38f-8a6f-4536-8033-251d2c52ae64 | 1 |
| 966225 | levothyroxine sodium 150 MCG Oral Tablet | SY | 2ecaa38f-8a6f-4536-8033-251d2c52ae64 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-3116-1 | 71335311601 | 30 TABLET in 1 BOTTLE (71335-3116-1) | 30 tablet | 2026-03-30 | No | No | Current |
| 71335-3116-2 | 71335311602 | 100 TABLET in 1 BOTTLE (71335-3116-2) | 100 tablet | 2026-03-30 | No | No | Current |
| 71335-3116-3 | 71335311603 | 90 TABLET in 1 BOTTLE (71335-3116-3) | 90 tablet | 2026-03-30 | No | No | Current |
| 71335-3116-4 | 71335311604 | 60 TABLET in 1 BOTTLE (71335-3116-4) | 60 tablet | 2026-03-30 | No | No | Current |