Prescription drug · NDA AUTHORIZED GENERIC
Levothyroxine Sodium NDC 51655-537
Levothyroxine sodium 175 ug/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-537-52 | 51655053752 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-537-52)Marketed from Dec 28, 2022 |
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)
- Levothyroxine Sodium
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 175 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021342
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 51655-537_4a29f1d4-e310-07f1-e063-6294a90aed4bSPL ID 4a29f1d4-e310-07f1-e063-6294a90aed4bSPL set ID f31b5d54-7536-4290-e053-2a95a90ac235RxCUI 966249UNII 9J765S329G
- 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
N451655053752followed by a unit qualifier and the quantityPackage 51655-0537-52. 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)
Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: • Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induc…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021342
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 50 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-532 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1814 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Proficient Rx LP | 71205-655 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-579 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-576 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-578 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-583 |
| Levothyroxine Sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-128 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1499 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2278 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Lannett Company, Inc | 0527-3280 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Lannett Company, Inc | 0527-3281 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Lannett Company, Inc | 0527-3282 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Lannett Company, Inc | 0527-3283 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Proficient Rx LP | 82804-222 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Lannett Company, Inc | 0527-3284 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-728 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | A-S Medication Solutions | 50090-5654 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1940 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Lannett Company, Inc | 0527-3285 |
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