Levothyroxine Sodium
- Product NDC
- 68788-8896
- 11-digit product format
- 687888896
- Labeler code
- 68788
- Product ID
- 68788-8896_884f9fa1-58aa-4ff7-934f-106a0470e747
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209713
- Marketing category
- ANDA
- Marketing start
- 2025-07-03
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- .075 mg/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8896_884f9fa1-58aa-4ff7-934f-106a0470e747
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2025-07-03
- Marketing category
- ANDA
- Application number
- ANDA209713
- Pharmacologic classes
- Thyroxine [CS]; l-Thyroxine [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM | .075 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 966222 |
| Spl Set Id | 884f9fa1-58aa-4ff7-934f-106a0470e747 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9J765S329G | LEVOTHYROXINE SODIUM | 6106-07-6 | LEVOTHYROXINE SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8896-3 | 68788889603 | 30 TABLET in 1 BOTTLE (68788-8896-3) | 30 tablet | 2025-07-03 | No | No | Current |
| 68788-8896-9 | 68788889609 | 90 TABLET in 1 BOTTLE (68788-8896-9) | 90 tablet | 2025-07-03 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Levothyroxine Sodium | Preferred Pharmaceuticals Inc. | 2025-07-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |