levothyroxine sodium
- Product NDC
- 71335-2288
- 11-digit product format
- 713352288
- Labeler code
- 71335
- Product ID
- 71335-2288_1d8a4569-8d5f-4451-bd15-20815ea8e693
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021116
- Marketing category
- NDA
- Marketing start
- 2019-05-07
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 50 ug/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
- 71335-2288_1d8a4569-8d5f-4451-bd15-20815ea8e693
- SPL ID
- 1d8a4569-8d5f-4451-bd15-20815ea8e693
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- levothyroxine sodium
- Generic name
- levothyroxine sodium
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2019-05-07
- Marketing category
- NDA
- Application number
- NDA021116
- Pharmacologic classes
- Thyroxine [CS]; l-Thyroxine [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM | 50 ug/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 966221 |
| Spl Set Id | c1b0fbad-5816-4152-ab59-05079e8c2148 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2288-1 | 1000 TABLET in 1 BOTTLE (71335-2288-1) | 2024-04-03 | 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 | Sample | Exclude flag | Status |
|---|
| 71335-2288-1 | 71335228801 | 1000 TABLET in 1 BOTTLE (71335-2288-1) | 1000 tablet | 2024-04-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| levothyroxine sodium | Bryant Ranch Prepack | 2025-07-29 | HUMAN PRESCRIPTION DRUG LABEL | 102 |