Liothyronine Sodium
- Product NDC
- 59762-1206
- 11-digit product format
- 597621206
- Labeler code
- 59762
- Product ID
- 59762-1206_2534237c-0bd6-4b79-bc27-bd7aa8990ed7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- liothyronine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA010379
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-02-06
- Substance
- LIOTHYRONINE SODIUM
- Active strength
- 5 ug/1
- Pharmacologic classes
- Triiodothyronine [CS], l-Triiodothyronine [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 |
|---|---|---|---|---|---|---|---|
| N010379-001 | CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N010379-002 | CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N010379-003 | CYTOMEL | LIOTHYRONINE SODIUM | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N010379-001 | AB |
| N010379-002 | AB |
| N010379-003 | AB |
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 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-002 | CYTOMEL | EQ 0.025MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-003 | CYTOMEL | EQ 0.05MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N010379-001 | CYTOMEL | EQ 0.005MG BASE | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N010379-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N010379-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N010379-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010379-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N010379-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010379-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010379-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010379-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010379-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010379-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010379-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N010379-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010379-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010379-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010379-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N010379-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Liothyronine Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIOTHYRONINE SODIUM | 5 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| GCA9VV7D2N | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 115a84c2-0126-4dd7-816e-1873875f1e49 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b42496cd-a994-8ba1-597f-e507aa62246e | Product name | 5 | 20250116 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59762-1206-1 | Liothyronine Sodium | 100 in 1 BOTTLE | TABLET | 100 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-1206-1 | EA - Each | 59762-1206 | 470a650c-7153-4229-a47e-5dcc1b2025da | 1 | 2019-03-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59762-1206 | LIOTHYRONINE SODIUM TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250523_115a84c2-0126-4dd7-816e-1873875f1e49.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 |
|---|---|---|---|---|---|---|
| Liothyronine Sodium | LIOTHYRONINE SODIUM | Mylan Pharmaceuticals Inc. | 115a84c2-0126-4dd7-816e-1873875f1e49 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 010379 NDA010379 59762-1206 |
| Cytomel | LIOTHYRONINE SODIUM | Pfizer Laboratories Div Pfizer Inc | 51452b31-ff68-4e0c-b982-c15502ebf1d3 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | 010379 NDA010379 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 903697 | liothyronine sodium 25 MCG Oral Tablet | PSN | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903456 | liothyronine sodium 5 MCG Oral Tablet | PSN | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903703 | liothyronine sodium 50 MCG Oral Tablet | PSN | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903456 | liothyronine sodium 0.005 MG Oral Tablet | SCD | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903697 | liothyronine sodium 0.025 MG Oral Tablet | SCD | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903703 | liothyronine sodium 0.05 MG Oral Tablet | SCD | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903697 | liothyronine sodium 25 MCG Oral Tablet | SY | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903456 | liothyronine sodium 5 MCG Oral Tablet | SY | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
| 903703 | liothyronine sodium 50 MCG Oral Tablet | SY | 115a84c2-0126-4dd7-816e-1873875f1e49 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59762-1206-1 | 59762120601 | 100 TABLET in 1 BOTTLE (59762-1206-1) | 100 tablet | 2019-02-06 | 0000-00-00 | No | No | Current |