Prescription drug · ANDA
Levothyroxine sodium NDC 82804-149
Levothyroxine sodium 50 ug/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-149-30 | 82804014930 | 30 TABLET in 1 BOTTLE (82804-149-30)Marketed from Sep 20, 2024 | |
| 82804-149-90 | 82804014990 | 90 TABLET in 1 BOTTLE (82804-149-90)Marketed from Sep 20, 2024 |
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 — 50 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207588
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 82804-149_b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8SPL ID b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8SPL set ID b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8RxCUI 966221UNII 9J765S329GUPC 0382804149902
- 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
N482804014930followed by a unit qualifier and the quantityPackage 82804-0149-30. 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 in adult and pediatric patients, including neonates, 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 in adult and pediatric patients, including neonates, 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-sufficien…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207588
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 200 ug/1 | TabletOral | A-S Medication Solutions | 50090-7937 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8792 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8902 |
| Levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8687 |
| Levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8690 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | A-S Medication Solutions | 50090-7526 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8693 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | A-S Medication Solutions | 50090-7527 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2538 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8704 |
| Levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8710 |
| Levothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8718 |
| Levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2562 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8722 |
| Levothyroxine sodium | Levothyroxine sodium 300 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8725 |