Levothyroxine sodium
- Product NDC
- 0480-8693
- 11-digit product format
- 004808693
- Labeler code
- 0480
- Product ID
- 0480-8693_8f65417f-488f-4e4a-894c-56f99ed57d25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA207588
- Marketing category
- ANDA
- Marketing start
- 2022-09-21
- Marketing end
- 2026-11-30
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 88 ug/1
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 0480-8693_8f65417f-488f-4e4a-894c-56f99ed57d25
- SPL ID
- 8f65417f-488f-4e4a-894c-56f99ed57d25
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Levothyroxine sodium
- Generic name
- Levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2022-09-21
- Marketing end
- 2026-11-30
- Marketing category
- ANDA
- Application number
- ANDA207588
- Pharmacologic classes
- Thyroxine [CS]; l-Thyroxine [EPC]
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM | 88 ug/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270 |
| Spl Set Id | 60cadfd7-82b5-4207-97e1-1dd0655efb27 |
| Manufacturer Name | Teva Pharmaceuticals, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Marketing end | Sample |
|---|
| 0480-8693-10 | 1000 TABLET in 1 BOTTLE (0480-8693-10) | 2022-09-21 | 2026-11-30 | No |
| 0480-8693-98 | 90 TABLET in 1 BOTTLE (0480-8693-98) | 2022-09-21 | 2026-11-30 | No |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 0480-8693-10 | 00480869310 | 1000 TABLET in 1 BOTTLE (0480-8693-10) | 1000 tablet | 2022-09-21 | 2026-11-30 | No | No | Historical |
| 0480-8693-98 | 00480869398 | 90 TABLET in 1 BOTTLE (0480-8693-98) | 90 tablet | 2022-09-21 | 2026-11-30 | No | No | Historical |