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NDC 71858-0115-01 Tirosint 50 ug/mL Details
Tirosint 50 ug/mL
Tirosint is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by IBSA Pharma Inc.. The primary component is LEVOTHYROXINE SODIUM.
MedlinePlus Drug Summary
Levothyroxine is used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body. Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, heavy or irregular menstrual periods, and depression. When taken correctly, levothyroxine reverses these symptoms.
Related Packages: 71858-0115-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levothyroxine
Product Information
| NDC | 71858-0115 |
|---|---|
| Product ID | 71858-0115_0a4370a8-688c-7d96-e063-6294a90a18b8 |
| Associated GPIs | 28100010102035 |
| GCN Sequence Number | 076959 |
| GCN Sequence Number Description | levothyroxine sodium SOLUTION 50 MCG/ML ORAL |
| HIC3 | P3A |
| HIC3 Description | THYROID HORMONES |
| GCN | 42809 |
| HICL Sequence Number | 002849 |
| HICL Sequence Number Description | LEVOTHYROXINE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Tirosint |
| Proprietary Name Suffix | SOL |
| Non-Proprietary Name | Levothyroxine Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | ug/mL |
| Substance Name | LEVOTHYROXINE SODIUM |
| Labeler Name | IBSA Pharma Inc. |
| Pharmaceutical Class | Thyroxine [CS], l-Thyroxine [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA206977 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71858-0115-01 (71858011501)
| NDC Package Code | 71858-0115-1 |
|---|---|
| Billing NDC | 71858011501 |
| Package | 2 POUCH in 1 CARTON (71858-0115-1) / 5 AMPULE in 1 POUCH (71858-0115-4) / 1 mL in 1 AMPULE (71858-0115-6) |
| Marketing Start Date | 2019-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |