Prescription drug · ANDA
Levothyroxine Sodium NDC 33342-404
Levothyroxine sodium 300 ug/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-404-10 | 33342040410 | 90 TABLET in 1 BOTTLE (33342-404-10)Marketed from Dec 21, 2022 | |
| 33342-404-11 | 33342040411 | 100 TABLET in 1 BOTTLE (33342-404-11)Marketed from Dec 21, 2022 | |
| 33342-404-44 | 33342040444 | 1000 TABLET in 1 BOTTLE (33342-404-44)Marketed from Jan 24, 2023 |
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 — 300 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211417
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 33342-404_3a77ca51-7d8a-4755-aabc-3801cc772a10SPL ID 3a77ca51-7d8a-4755-aabc-3801cc772a10SPL set ID b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0333342393104, 0333342397102, 0333342404107, 0333342393111, 0333342400109, 0333342403100, 0333342393449, 0333342394101, 0333342402103, 0333342396105, 0333342395108, 0333342398109, 0333342399106
- 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
N433342040410followed by a unit qualifier and the quantityPackage 33342-0404-10. 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-sufficient …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211417
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 75 ug/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3887 |
| Levothyroxine Sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8811 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-403 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-401 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | TabletOral | A-S Medication Solutions | 50090-7885 |
| Levothyroxine Sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-402 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | TabletOral | A-S Medication Solutions | 50090-7886 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | A-S Medication Solutions | 50090-7901 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | TabletOral | A-S Medication Solutions | 50090-7909 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | TabletOral | A-S Medication Solutions | 50090-7636 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | A-S Medication Solutions | 50090-7902 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | TabletOral | A-S Medication Solutions | 50090-7637 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | TabletOral | A-S Medication Solutions | 50090-7910 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | A-S Medication Solutions | 50090-7648 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | A-S Medication Solutions | 50090-7649 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8806 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8807 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4005 |
| Levothyroxine Sodium | Levothyroxine sodium 200 ug/1 | TabletOral | A-S Medication Solutions | 50090-8059 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | TabletOral | A-S Medication Solutions | 50090-8056 |
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