Prescription drug · NDA
Unithroid (Levothyroxine sodium) NDC 60846-803
Levothyroxine sodium 75 ug/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60846-803-01 | 6084608030160846080301 | 100 TABLET in 1 BOTTLE (60846-803-01)Marketed from Jul 3, 2014 |
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)
- Unithroid
- Generic name (nonproprietary)
- levothyroxine sodium
- Active ingredients
- Levothyroxine sodium — 75 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 60846
- 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 60846-803_35a7647b-9644-4c4c-8011-a0d5969c0a56SPL ID 35a7647b-9644-4c4c-8011-a0d5969c0a56SPL set ID 07562e72-7eaa-4ce6-94f0-e08814787e50RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966228, 966232, 966233, 966235, 966237, 966238, 966241, 966243, 966244, 966246, 966248, 966249, 966253, 966270, 966286, 966436UNII 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
N460846080301followed by a unit qualifier and the quantityPackage 60846-0803-01. 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)
Hypothyroidism UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: UNITHROID is 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 UNITHROID may induce hyperthyroidis…
Excerpt only. Read the full label for complete information.
About NDC 60846-803
- What is NDC 60846-803?
- 60846-803 is the product NDC for Unithroid (levothyroxine sodium), Levothyroxine sodium 75 ug/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Unithroid (Levothyroxine sodium).
- What is the active ingredient?
- Levothyroxine sodium.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 60846. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Unithroid?
- 11 other product NDCs are listed under this name. See all Unithroid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Unithroid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Unithroidlevothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-801 | 60846-0801-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-802 | 60846-0802-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-804 | 60846-0804-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-805 | 60846-0805-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-806 | 60846-0806-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-807 | 60846-0807-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-808 | 60846-0808-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-809 | 60846-0809-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-810 | 60846-0810-01 |
| Unithroidlevothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Amneal Pharmaceuticals LLC | 60846-811 | 60846-0811-01 |
Other NDCs under NDA 021210
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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