Prescription drug · ANDA
Liothyronine Sodium NDC 42794-019
Liothyronine sodium 25 ug/1 · Tablet · Oral · SIGMAPHARM LABORATORIES, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42794-019-02 | 42794001902 | 100 TABLET in 1 BOTTLE (42794-019-02)Marketed from Dec 3, 2012 | |
| 42794-019-06 | 42794001906 | 1000 TABLET in 1 BOTTLE (42794-019-06)Marketed from Dec 3, 2012 | |
| 42794-019-12 | 42794001912 | 90 TABLET in 1 BOTTLE (42794-019-12)Marketed from May 1, 2018 |
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 — 25 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SIGMAPHARM LABORATORIES, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200295
- Marketing start
- Listing expires
- Other FDA classes
- Triiodothyronine (Chemical structure)
- Identifiers
- Product ID 42794-019_f1f181e3-ceed-1d17-e053-2995a90af5cdSPL ID f1f181e3-ceed-1d17-e053-2995a90af5cdSPL set ID 38ef3766-bb9a-402e-9e4a-ad8bb5b26e4cRxCUI 903456, 903697, 903703UNII GCA9VV7D2NUPC 0342794018121, 0342794019128, 0342794020124
- 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
N442794001902followed by a unit qualifier and the quantityPackage 42794-0019-02. 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)
Liothyronine sodium 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 Thyrotropin (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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200295
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 | NuCare Pharmaceuticals,Inc. | 68071-3571 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | A-S Medication Solutions | 50090-3131 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-0341 |
| Liothyronine Sodium | Liothyronine sodium 25 ug/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-884 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7269 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | SIGMAPHARM LABORATORIES, LLC | 42794-018 |
| Liothyronine Sodium | Liothyronine sodium 50 ug/1 | TabletOral | SIGMAPHARM LABORATORIES, LLC | 42794-020 |
| Liomnyliothyronine sodium | Liothyronine sodium 5 ug/1 | TabletOral | SIGMAPHARM LABORATORIES, LLC | 42794-131 |
| Liomnyliothyronine sodium | Liothyronine sodium 25 ug/1 | TabletOral | SIGMAPHARM LABORATORIES, LLC | 42794-132 |
| Liomnyliothyronine sodium | Liothyronine sodium 50 ug/1 | TabletOral | SIGMAPHARM LABORATORIES, LLC | 42794-133 |
| Liothyronine Sodium | Liothyronine sodium 50 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-9632 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | Proficient Rx LP | 71205-150 |
| Liothyronine Sodium | Liothyronine sodium 5 ug/1 | TabletOral | ASCLEMED USA INC. | 87063-080 |
| Liothyronine Sodium | Liothyronine sodium 25 ug/1 | TabletOral | ASCLEMED USA INC. | 87063-081 |
| Liothyronine Sodium | Liothyronine sodium 50 ug/1 | TabletOral | ASCLEMED USA INC. | 87063-082 |
| Liothyronine Sodium | Liothyronine sodium 25 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-0166 |