LEVOTHYROXINE SODIUM
- Product NDC
- 70710-1833
- 11-digit product format
- 707101833
- Labeler code
- 70710
- Product ID
- 70710-1833_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA217066
- Marketing category
- ANDA
- Marketing start
- 2024-11-01
- Substance
- LEVOTHYROXINE SODIUM ANHYDROUS
- Active strength
- 100 ug/5mL
- 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
- 70710-1833_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- LEVOTHYROXINE SODIUM
- Generic name
- levothyroxine sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing start
- 2024-11-01
- Marketing category
- ANDA
- Application number
- ANDA217066
- Pharmacologic classes
- Thyroxine [CS]; l-Thyroxine [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LEVOTHYROXINE SODIUM ANHYDROUS | 100 ug/5mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 054I36CPMN |
| Rxcui | 966219, 1115267, 1115269 |
| Spl Set Id | bf8a952c-f05b-4814-b55a-ed04be015269 |
| Manufacturer Name | Zydus Pharmaceuticals USA Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 054I36CPMN | LEVOTHYROXINE SODIUM ANHYDROUS | 55-03-8 | LEVOTHYROXINE SODIUM ANHYDROUS |
| 9J765S329G | LEVOTHYROXINE SODIUM | 6106-07-6 | levothyroxine sodium |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1833-1 | 70710183301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1833-1) / 5 mL in 1 VIAL, SINGLE-DOSE | 2024-11-01 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| LEVOTHYROXINE SODIUM | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-09-16 | HUMAN PRESCRIPTION DRUG LABEL | 4 |