Levothyroxine sodium
- Product NDC
- 82804-168
- 11-digit product format
- 828040168
- Labeler code
- 82804
- Product ID
- 82804-168_678b11e4-a8a5-4b9a-a937-517c9320372f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212399
- Marketing category
- ANDA
- Marketing start
- 2020-12-10
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 25 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 | 25 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 966220 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-168-30 | Levothyroxine sodium | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 82804-168-90 | Levothyroxine sodium | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-168 | LEVOTHYROXINE SODIUM TABLET [PROFICIENT RX LP] | 2 | Current NDC, 2 package rows | 20241228_576dcd01-d151-42ac-acd1-480a13bae176.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 |
|---|
| 82804-168-30 | 82804016830 | 30 TABLET in 1 BOTTLE (82804-168-30) | 30 tablet | 2024-12-09 | No | No | Current |
| 82804-168-90 | 82804016890 | 90 TABLET in 1 BOTTLE (82804-168-90) | 90 tablet | 2024-12-23 | No | No | Current |