Levothyroxine Sodium
- Product NDC
- 63323-649
- Requested package NDC
- 63323-649-16
- 11-digit product format
- 633230649
- Labeler code
- 63323
- Product ID
- 63323-649_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOTHYROXINE SODIUM ANHYDROUS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA202231
- Marketing category
- NDA
- Marketing start
- 2011-06-24
- Substance
- LEVOTHYROXINE SODIUM ANHYDROUS
- Active strength
- 100 ug/5mL
- 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 |
|---|---|---|---|---|---|---|---|
| N202231-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 |
| N202231-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 |
| N202231-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N202231-001 | AP |
| N202231-002 | AP |
| N202231-003 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | |
| N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-002 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-002 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | |
| N202231-003 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-003 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | |
| N202231-003 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 |
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 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-002 | LEVOTHYROXINE SODIUM | 200MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-003 | LEVOTHYROXINE SODIUM | 500MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202231-001 | LEVOTHYROXINE SODIUM | 100MCG/VIAL | POWDER / INTRAVENOUS | AP | RLD, RS | 2011-06-24 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202231-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202231-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N202231-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202231-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202231-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202231-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202231-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202231-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202231-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202231-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202231-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202231-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202231-001 | AP | 1 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-002 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-002 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-003 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-003 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202231-003 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-002 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-002 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-003 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-003 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202231-003 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-002 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-002 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-003 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-003 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202231-003 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-002 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-002 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-003 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-003 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202231-003 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-001 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-001 | 9168239 | 2032-08-29 | Drug product | 2015-10-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-001 | 9006289 | 2032-10-03 | Drug product | 2015-04-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202231-002 | 9168238 | 2032-08-29 | Drug product | 2015-10-28 | 6a471c1ec25d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOTHYROXINE SODIUM ANHYDROUS | 100 ug/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 054I36CPMN | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ce990712-49c1-4f66-9ee4-c770e8ec394c | 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 |
|---|---|---|---|---|---|---|
| 63323-649-07 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 7 | |
| 63323-649-07 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | 7 | |
| 63323-649-16 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 5 | |
| 63323-649-16 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | 5 | |
| 63323-649-94 | Levothyroxine Sodium | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 5 | |
| 63323-649-94 | Levothyroxine Sodium | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-649-07 | EA - Each | 63323-649 | cb7bc2dd-660a-4b21-ae7b-38a512e1a399 | 1 | 2012-07-24 |
| 63323-649-16 | EA - Each | 63323-649 | 4e91632c-ec5e-4c98-8be7-0501f01ff060 | 1 | 2014-12-01 |
| 63323-649-94 | EA - Each | 63323-649 | 618c16fd-98bc-4a24-ad86-60806a2178e6 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-649 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250426_ce990712-49c1-4f66-9ee4-c770e8ec394c.zip |
| 63323-649 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241019_152d071f-d4aa-46d2-b397-61c1cabdd86d.zip |
| 63323-649 | LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM ANHYDROUS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241019_f88f44d8-2f18-4155-9d78-6323d19fbafe.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 ANHYDROUS | ENDO USA, Inc. | 9d815416-11c9-470e-a82f-89b0bf232e12 | 2025-04-28 | Boxed warning, Warnings, Adverse reactions | 202231 NDA202231 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | ce990712-49c1-4f66-9ee4-c770e8ec394c | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 202231 NDA202231 63323-649 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | 202231 NDA202231 63323-649 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | f88f44d8-2f18-4155-9d78-6323d19fbafe | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | 202231 NDA202231 63323-649-16 63323-649 63323064916 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115267 | levothyroxine sodium 100 MCG Injection | PSN | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115269 | levothyroxine sodium 200 MCG Injection | PSN | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 966219 | levothyroxine sodium 500 MCG Injection | PSN | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115267 | levothyroxine sodium 0.1 MG Injection | SCD | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115269 | levothyroxine sodium 0.2 MG Injection | SCD | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 966219 | levothyroxine sodium 0.5 MG Injection | SCD | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115267 | levothyroxine sodium 100 MCG Injection | SY | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115269 | levothyroxine sodium 200 MCG Injection | SY | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 966219 | levothyroxine sodium 500 MCG Injection | SY | ce990712-49c1-4f66-9ee4-c770e8ec394c | 7 |
| 1115267 | levothyroxine sodium 100 MCG Injection | PSN | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
| 1115267 | levothyroxine sodium 100 MCG Injection | PSN | f88f44d8-2f18-4155-9d78-6323d19fbafe | 5 |
| 966219 | levothyroxine sodium 500 MCG Injection | PSN | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
| 1115267 | levothyroxine sodium 0.1 MG Injection | SCD | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
| 1115267 | levothyroxine sodium 0.1 MG Injection | SCD | f88f44d8-2f18-4155-9d78-6323d19fbafe | 5 |
| 966219 | levothyroxine sodium 0.5 MG Injection | SCD | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
| 1115267 | levothyroxine sodium 100 MCG Injection | SY | f88f44d8-2f18-4155-9d78-6323d19fbafe | 5 |
| 1115267 | levothyroxine sodium 100 MCG Injection | SY | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
| 966219 | levothyroxine sodium 500 MCG Injection | SY | 152d071f-d4aa-46d2-b397-61c1cabdd86d | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63323-649-16 | 63323064916 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-649-16) / 5 mL in 1 VIAL, SINGLE-DOSE | 2011-06-24 | 0000-00-00 | No | No | Current |