Prescription drug · ANDA
Liothyronine sodium NDC 68382-582
Liothyronine sodium 5 ug/1 · Tablet · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-582-01 | 68382058201 | 100 TABLET in 1 BOTTLE (68382-582-01)Marketed from Feb 1, 2021 | |
| 68382-582-10 | 68382058210 | 1000 TABLET in 1 BOTTLE (68382-582-10)Marketed from Feb 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Liothyronine sodium
- Generic name (nonproprietary)
- liothyronine sodium
- Active ingredients
- Liothyronine sodium — 5 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214803
- Marketing start
- Listing expires
- Other FDA classes
- Triiodothyronine (Chemical structure)
- Identifiers
- Product ID 68382-582_04696ad1-0a11-4e94-b4d2-c4b66d688b3bSPL ID 04696ad1-0a11-4e94-b4d2-c4b66d688b3bSPL set ID c54cf95f-6465-4203-b98b-a54ba5a26843RxCUI 903456, 903697, 903703UNII GCA9VV7D2N
- Pharmacologic class
- l-Triiodothyronine
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
N468382058201followed by a unit qualifier and the quantityPackage 68382-0582-01. 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)
Liothyronine is an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1) - Not indicated for treatmen…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214803
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 |
|---|---|---|---|---|
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Zydus Lifesciences Limited | 70771-1606 |
| Liothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | Zydus Lifesciences Limited | 70771-1607 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Zydus Lifesciences Limited | 70771-1608 |
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Northstar Rx LLC | 16714-166 |
| Liothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | Northstar Rx LLC | 16714-167 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Northstar Rx LLC | 16714-168 |
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | A-S Medication Solutions | 50090-5586 |
| Liothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1943 |
| Liothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-583 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 68382-584 |
| Liothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1978 |
| Liothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2001 |