Tirosint
- Product NDC
- 71858-0117
- 11-digit product format
- 718580117
- Labeler code
- 71858
- Product ID
- 71858-0117_4e04737b-8d88-7c75-e063-6394a90a34c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levothyroxine Sodium
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- IBSA Pharma Inc.
- Application
- NDA206977
- Marketing category
- NDA
- Marketing start
- 2021-07-01
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 62.5 ug/mL
- Pharmacologic classes
- Thyroxine [CS], l-Thyroxine [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|
| 71858-0117-2 | 71858011702 | 6 POUCH in 1 CARTON (71858-0117-2) / 5 AMPULE in 1 POUCH (71858-0117-4) / 1 mL in 1 AMPULE (71858-0117-6) | 6 pouch | 2025-07-25 | Yes | No | Historical |
| 71858-0117-5 | 71858011705 | 6 POUCH in 1 CARTON (71858-0117-5) / 5 AMPULE in 1 POUCH (71858-0117-4) / 1 mL in 1 AMPULE (71858-0117-6) | 6 pouch | 2021-07-01 | No | No | Historical |