levothyroxine sodium
- Product NDC
- 71335-1435
- 11-digit product format
- 713351435
- Labeler code
- 71335
- Product ID
- 71335-1435_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
- 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
- 200 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
- 71335-1435_5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
- SPL ID
- 5dd258ee-53fd-4e60-b3c9-b3cfacd622bf
- 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 | 200 ug/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9J765S329G |
| Rxcui | 892246, 892251, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270 |
| Spl Set Id | 9e3bffb9-f66e-4c73-befc-e60d769f6610 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1435-1 | 100 TABLET in 1 BOTTLE (71335-1435-1) | 2019-12-12 | No |
| 71335-1435-2 | 30 TABLET in 1 BOTTLE (71335-1435-2) | 2019-12-12 | No |
| 71335-1435-3 | 90 TABLET in 1 BOTTLE (71335-1435-3) | 2019-12-12 | No |
| 71335-1435-4 | 60 TABLET in 1 BOTTLE (71335-1435-4) | 2019-12-12 | No |
| 71335-1435-5 | 18 TABLET in 1 BOTTLE (71335-1435-5) | 2019-12-12 | 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 |
|---|
| 71335-1435-1 | 71335143501 | 100 TABLET in 1 BOTTLE (71335-1435-1) | 100 tablet | 2019-12-12 | No | No | Historical |
| 71335-1435-2 | 71335143502 | 30 TABLET in 1 BOTTLE (71335-1435-2) | 30 tablet | 2019-12-12 | No | No | Historical |
| 71335-1435-3 | 71335143503 | 90 TABLET in 1 BOTTLE (71335-1435-3) | 90 tablet | 2019-12-12 | No | No | Historical |
| 71335-1435-4 | 71335143504 | 60 TABLET in 1 BOTTLE (71335-1435-4) | 60 tablet | 2019-12-12 | No | No | Historical |
| 71335-1435-5 | 71335143505 | 18 TABLET in 1 BOTTLE (71335-1435-5) | 18 tablet | 2019-12-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| levothyroxine sodium | Bryant Ranch Prepack | 2025-07-29 | HUMAN PRESCRIPTION DRUG LABEL | 26 |