Levothyroxine sodium
- Product NDC
- 82804-053
- 11-digit product format
- 828040053
- Labeler code
- 82804
- Product ID
- 82804-053_89df6a0f-6602-4c22-a052-b565ea8368a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212399
- Marketing category
- ANDA
- Marketing start
- 2020-11-25
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 75 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levothyroxine sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM | 75 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 966222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-053-30 | Levothyroxine sodium | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 82804-053-60 | Levothyroxine sodium | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 82804-053-90 | Levothyroxine sodium | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-053 | LEVOTHYROXINE SODIUM TABLET [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20231230_89df6a0f-6602-4c22-a052-b565ea8368a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-053-30 | 82804005330 | 30 TABLET in 1 BOTTLE (82804-053-30) | 30 tablet | 2023-12-28 | No | No | Current |
| 82804-053-60 | 82804005360 | 60 TABLET in 1 BOTTLE (82804-053-60) | 60 tablet | 2023-12-28 | No | No | Current |
| 82804-053-90 | 82804005390 | 90 TABLET in 1 BOTTLE (82804-053-90) | 90 tablet | 2023-12-28 | No | No | Current |