Prescription drug · NDA
Tirosint (Levothyroxine sodium) NDC 71858-0050
Levothyroxine sodium 150 ug/1 · Capsule · Oral · IBSA Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71858-0050-2 | 7185800500271858005002 | 3 BLISTER PACK in 1 CARTON (71858-0050-2) / 10 CAPSULE in 1 BLISTER PACKMarketed from Aug 24, 2025 · Sample package | |
| 71858-0050-4 | 7185800500471858005004 | 3 BLISTER PACK in 1 CARTON (71858-0050-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from Dec 1, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tirosint
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 150 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- IBSA Pharma Inc.NDC labeler code 71858
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021924
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 71858-0050_4ddc8742-bf50-baa5-e063-6294a90a56ebSPL ID 4ddc8742-bf50-baa5-e063-6294a90a56ebSPL set ID 7a7ade79-0165-4e31-b84e-667416c00c7eRxCUI 905451, 905453, 905455, 905457, 905458, 905460, 905462, 905464, 966404, 966405, 966406, 966407, 966412, 966413, 966415, 966417, 966420, 966423, 966426, 966434, 1923047, 1923049, 1923050, 1923052, 2630738, 2630740, 2630742, 2630744, 2630746, 2630748UNII 9J765S329GUPC 0371858005548, 0371858005043, 0371858006040, 0371858001540, 0371858003544, 0371858001243, 0371858003049, 0371858001045, 0371858001748, 0371858004046, 0371858001342, 0371858000543, 0371858002547, 0371858004541, 0371858002042
- Pharmacologic class
- l-Thyroxine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471858005002followed by a unit qualifier and the quantityPackage 71858-0050-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
1 INDICATION AND USAGE TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery p…
Excerpt only. Read the full label for complete information.
About NDC 71858-0050
- What is NDC 71858-0050?
- 71858-0050 is the product NDC for Tirosint (levothyroxine sodium), Levothyroxine sodium 150 ug/1 capsule, listed with the FDA by IBSA Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tirosint (Levothyroxine sodium).
- What is the active ingredient?
- Levothyroxine sodium.
- Who is the labeler?
- IBSA Pharma Inc., NDC labeler code 71858. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tirosint?
- 14 other product NDCs are listed under this name. See all Tirosint NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tirosint products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tirosintlevothyroxine sodium | Levothyroxine sodium 37.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0012 | 71858-0012-0271858-0012-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 44 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0013 | 71858-0013-0271858-0013-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 62.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0017 | 71858-0017-0271858-0017-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 13 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0005 | 71858-0005-0271858-0005-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0010 | 71858-0010-0271858-0010-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0015 | 71858-0015-0271858-0015-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0020 | 71858-0020-0271858-0020-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0025 | 71858-0025-0271858-0025-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0030 | 71858-0030-0271858-0030-04 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0035 | 71858-0035-0271858-0035-04 |
Other NDCs under NDA 021924
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0020 |
| Levothyroxine Sodium | Levothyroxine sodium 13 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0005 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0010 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0015 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0035 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0025 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0030 |
| Levothyroxine Sodium | Levothyroxine sodium 175 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0055 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0040 |
| Levothyroxine Sodium | Levothyroxine sodium 137 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0045 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0050 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | CapsuleOral | YARAL Pharma Inc. | 82347-0060 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0010 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 13 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0005 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 62.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0017 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 37.5 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0012 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 44 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0013 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0015 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0030 |
| Tirosintlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | CapsuleOral | IBSA Pharma Inc. | 71858-0020 |
Showing 20 of 26.