EUTHYROX
- Product NDC
- 72305-088
- 11-digit product format
- 723050088
- Labeler code
- 72305
- Product ID
- 72305-088_f44b3b8b-ec92-4925-be14-01a86b66f395
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Provell Pharmaceuticals, LLC
- Application
- NDA021292
- Marketing category
- NDA
- Marketing start
- 2018-10-17
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 88 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 72305-088 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 72305-088 | 72305-088-30 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 72305-088 | 72305-088-90 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021292-001 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-002 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-003 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-004 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-005 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-006 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-007 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-008 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.137MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-009 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.15MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-010 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.175MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-011 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.2MG | TABLET / ORAL | 2002-05-31 | ||
| N021292-012 | EUTHYROX | LEVOTHYROXINE SODIUM | 0.3MG | TABLET / ORAL | 2002-05-31 |
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 | N021292-001 | EUTHYROX | 0.025MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-002 | EUTHYROX | 0.05MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-003 | EUTHYROX | 0.075MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-004 | EUTHYROX | 0.088MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-005 | EUTHYROX | 0.1MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-006 | EUTHYROX | 0.112MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-007 | EUTHYROX | 0.125MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-008 | EUTHYROX | 0.137MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-009 | EUTHYROX | 0.15MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-010 | EUTHYROX | 0.175MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-011 | EUTHYROX | 0.2MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021292-012 | EUTHYROX | 0.3MG | TABLET / ORAL | 2002-05-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-001 | EUTHYROX | 0.025MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-002 | EUTHYROX | 0.05MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-003 | EUTHYROX | 0.075MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-004 | EUTHYROX | 0.088MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-005 | EUTHYROX | 0.1MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-006 | EUTHYROX | 0.112MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-007 | EUTHYROX | 0.125MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-008 | EUTHYROX | 0.137MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-009 | EUTHYROX | 0.15MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-010 | EUTHYROX | 0.175MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-011 | EUTHYROX | 0.2MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021292-012 | EUTHYROX | 0.3MG | TABLET / ORAL | 2002-05-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021292-001 | EUTHYROX | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-002 | EUTHYROX | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-003 | EUTHYROX | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-004 | EUTHYROX | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-005 | EUTHYROX | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-006 | EUTHYROX | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-007 | EUTHYROX | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-008 | EUTHYROX | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-009 | EUTHYROX | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-010 | EUTHYROX | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-011 | EUTHYROX | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-012 | EUTHYROX | 0.3MG | TABLET / ORAL | 2002-05-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-001 | EUTHYROX | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-002 | EUTHYROX | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-003 | EUTHYROX | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-004 | EUTHYROX | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2002-05-31 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021292-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-005 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-006 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-007 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-008 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-009 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-010 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021292-011 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-006 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-007 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-008 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-009 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-010 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021292-011 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-005 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-006 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-007 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-008 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-009 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-010 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021292-011 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-004 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-005 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-006 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021292-007 | AB2 | 1 | fd3edfee7708… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72305-088-30 | EUTHYROX | 2 in 1 CARTON | TABLET | 2 | 10 | |
| 72305-088-30 | EUTHYROX | 15 in 1 BLISTER PACK | TABLET | 15 | 10 | |
| 72305-088-90 | EUTHYROX | 6 in 1 CARTON | TABLET | 6 | 10 | |
| 72305-088-90 | EUTHYROX | 15 in 1 BLISTER PACK | TABLET | 15 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72305-088-30 | EA - Each | 72305-088 | a1049b43-7571-467c-b50f-9bfab06d32bc | 1 | 2018-12-13 |
| 72305-088-90 | EA - Each | 72305-088 | 1edb2515-06bb-4b3c-b564-6958e06d808b | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| EUTHYROX | LEVOTHYROXINE SODIUM | Provell Pharmaceuticals, LLC | bc3c6830-ba68-4ba3-9896-a12d0ad0b275 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 021292 NDA021292 72305-088 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72305-088-30 | 72305008830 | 2 BLISTER PACK in 1 CARTON (72305-088-30) > 15 TABLET in 1 BLISTER PACK | 2 blister pack | 2018-10-17 | 0000-00-00 | No | No | Current |
| 72305-088-90 | 72305008890 | 6 BLISTER PACK in 1 CARTON (72305-088-90) > 15 TABLET in 1 BLISTER PACK | 6 blister pack | 2022-09-30 | 0000-00-00 | No | No | Current |