Levothyroxine sodium
- Product NDC
- 50436-5182
- 11-digit product format
- 504365182
- Labeler code
- 50436
- Product ID
- 50436-5182_019cb229-ac81-4ece-802f-949805a7c26e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- NDA021342
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2002-03-01
- Marketing end
- 0000-00-00
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 75 ug/1
- Pharmacologic classes
- l-Thyroxine [EPC],Thyroxine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-5182-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e83-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-5182-1 | Levothyroxine sodium | 30 in 1 BOTTLE | TABLET | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-5182 | LEVOTHYROXINE SODIUM TABLET [UNIT DOSE SERVICES] | 5 | Legacy NDC, 1 package rows | 20181010_7ac30fc2-7d82-4395-bab6-778333d2d9c2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | PSN | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | PSN | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | PSN | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966221 | levothyroxine sodium 0.05 MG Oral Tablet | SCD | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966222 | levothyroxine sodium 0.075 MG Oral Tablet | SCD | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966253 | levothyroxine sodium 0.088 MG Oral Tablet | SCD | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966221 | levothyroxine sodium 50 MCG Oral Tablet | SY | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966222 | levothyroxine sodium 75 MCG Oral Tablet | SY | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
| 966253 | levothyroxine sodium 88 MCG Oral Tablet | SY | 7ac30fc2-7d82-4395-bab6-778333d2d9c2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-5182-1 | 50436518201 | 30 in 1 BOTTLE | Historical |