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Brand-name prescription medicine

Tirosint SOL

Generic name: Levothyroxine

FDA application holder: Ibsa

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

15Strengths and forms
0Same medicine, other names
2016FDA approval
15Recalls (FDA reports)

Quick answers

What is Tirosint SOL?
Tirosint SOL is a brand name of Levothyroxine, a prescription medicine. The FDA NDC Directory lists 15 Tirosint SOL products in 15 strengths and forms.
Who makes Tirosint SOL?
Ibsa holds the FDA application for Tirosint SOL (NDA206977, approved December 15, 2016).
Is there a generic or store brand of Tirosint SOL?
Other products of Levothyroxine are listed with the FDA, but none in exactly the same strength and form as a Tirosint SOL product.
Has Tirosint SOL been recalled?
FDA enforcement reports list 15 recalls of Tirosint SOL products; the newest started January 30, 2023. A recall usually concerns specific lots, not every product.

What Tirosint SOL is

Each Tirosint SOL product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Levothyroxine · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
levothyroxine sodium 100 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 112 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 125 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 13 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 137 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 150 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 175 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 200 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 25 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 37.5 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 44 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 50 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 62.5 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 75 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed
levothyroxine sodium 88 ug/mL
solution (oral)		 Tirosint SOL None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Levothyroxine →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Tirosint SOL products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA206977IbsaDecember 15, 201615

Companies that list Tirosint SOL

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tirosint SOL products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. January 30, 2023 · Class II · Terminated · D-0335-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  2. January 30, 2023 · Class II · Terminated · D-0341-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  3. January 30, 2023 · Class II · Terminated · D-0345-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  4. January 30, 2023 · Class II · Terminated · D-0336-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  5. January 30, 2023 · Class II · Terminated · D-0331-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  6. January 30, 2023 · Class II · Terminated · D-0344-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  7. January 30, 2023 · Class II · Terminated · D-0340-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  8. January 30, 2023 · Class II · Terminated · D-0337-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  9. January 30, 2023 · Class II · Terminated · D-0338-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P — IBSA PHARMA INC

  10. January 30, 2023 · Class II · Terminated · D-0334-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  11. January 30, 2023 · Class II · Terminated · D-0332-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  12. January 30, 2023 · Class II · Terminated · D-0343-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  13. January 30, 2023 · Class II · Terminated · D-0339-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  14. January 30, 2023 · Class II · Terminated · D-0342-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

  15. January 30, 2023 · Class II · Terminated · D-0333-2023

    Subpotent Drug

    TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA — IBSA PHARMA INC

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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