Levothyroxine sodium
- Product NDC
- 0781-5186
- 11-digit product format
- 007815186
- Labeler code
- 0781
- Product ID
- 0781-5186_b6216747-5ffb-6cd7-e053-2995a90a5ca0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc.
- Application
- NDA021342
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2002-03-01
- Marketing end
- 2021-12-31
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 125 ug/1
- Pharmacologic classes
- l-Thyroxine [EPC],Thyroxine [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-5186-01 | EA - Each | 0781-5186 | 9c899622-c6b5-4907-bc4d-5dc00ab6f99c | 1 | 2012-07-24 |
| 0781-5186-10 | EA - Each | 0781-5186 | 0a2f28da-7c1b-4296-a534-60cd51a70564 | 1 | 2012-07-24 |
| 0781-5186-92 | EA - Each | 0781-5186 | 85b4aa37-3778-4088-9eae-ed36045238dd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | ACTIVE INGREDIENT | 9J765S329G | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LEVOTHYROXINE | ACTIVE MOIETY | Q51BO43MG4 | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LEVOTHYROXINE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | PSN | 69de922e-931e-4723-a91f-0cd774f008d1 | 1 |
| 966224 | levothyroxine sodium 0.125 MG Oral Tablet | SCD | 69de922e-931e-4723-a91f-0cd774f008d1 | 1 |
| 966224 | levothyroxine sodium 125 MCG Oral Tablet | SY | 69de922e-931e-4723-a91f-0cd774f008d1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-5186-10 | 00781518610 | 1000 TABLET in 1 BOTTLE (0781-5186-10) | 1000 tablet | 2002-03-01 | 2021-12-31 | No | No | Current |
| 0781-5186-92 | 00781518692 | 90 TABLET in 1 BOTTLE (0781-5186-92) | 90 tablet | 2012-04-16 | 2021-12-31 | No | No | Current |