Tirosint
- Product NDC
- 71858-0012
- 11-digit product format
- 718580012
- Labeler code
- 71858
- Product ID
- 71858-0012_4ddc8742-bf50-baa5-e063-6294a90a56eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levothyroxine sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- IBSA Pharma Inc.
- Application
- NDA021924
- Marketing category
- NDA
- Marketing start
- 2023-03-01
- Substance
- LEVOTHYROXINE SODIUM
- Active strength
- 37.5 ug/1
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71858-0012-1 | 71858001201 | 1 BLISTER PACK in 1 CARTON (71858-0012-1) / 10 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2023-03-01 | 2026-07-22 | Yes | No | Historical |
| 71858-0012-2 | 71858001202 | 3 BLISTER PACK in 1 CARTON (71858-0012-2) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2025-08-24 | | Yes | No | Historical |
| 71858-0012-4 | 71858001204 | 3 BLISTER PACK in 1 CARTON (71858-0012-4) / 10 CAPSULE in 1 BLISTER PACK | 3 blister pack | 2023-03-01 | | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tirosint | IBSA Pharma Inc. | 2026-03-25 | HUMAN PRESCRIPTION DRUG LABEL | 13 |