Prescription drug · NDA
Levothyroxine Sodium NDC 0615-8597
Levothyroxine sodium .075 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8597-05 | 00615859705 | 15 TABLET in 1 BLISTER PACK (0615-8597-05)Marketed from Jan 8, 2026 | |
| 0615-8597-14 | 00615859714 | 14 TABLET in 1 BLISTER PACK (0615-8597-14)Marketed from Jan 8, 2026 | |
| 0615-8597-39 | 00615859739 | 30 TABLET in 1 BLISTER PACK (0615-8597-39)Marketed from Jan 8, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .075 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021210
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 0615-8597_4caa5e76-0e12-4c19-9cc7-af7365f7dc90SPL ID 4caa5e76-0e12-4c19-9cc7-af7365f7dc90SPL set ID abe173cc-1579-43a5-b12d-a31958d0a539RxCUI 892246, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 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
N400615859705followed by a unit qualifier and the quantityPackage 00615-8597-05. 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)
INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatme…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021210
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 .175 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8651 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-513 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8598 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-557 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-802 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-801 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-806 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-803 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-804 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8599 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-805 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-807 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-808 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-809 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-810 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-811 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 300 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-812 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8600 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8573 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-687 |
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