Prescription drug · ANDA
Levothyroxine Sodium NDC 0378-1823
Levothyroxine sodium 137 ug/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-1823-10 | 00378182310 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1823-10)Marketed from Feb 26, 2008 | |
| 0378-1823-77 | 00378182377 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-1823-77)Marketed from Jun 16, 2016 |
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 — 137 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076187
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 0378-1823_ca193039-55b1-4a7e-aa67-c4bff4f9f5b0SPL ID ca193039-55b1-4a7e-aa67-c4bff4f9f5b0SPL set ID e95720f2-91c9-a6d0-f7d5-8bcb94d07bbcRxCUI 892246, 892251, 892255, 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
N400378182310followed by a unit qualifier and the quantityPackage 00378-1823-10. 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-sufficien…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076187
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 88 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-529 |
| Levothyroxine Sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Mylan Institutional Inc. | 42292-041 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Mylan Institutional Inc. | 42292-038 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Mylan Institutional Inc. | 42292-039 |
| Levothyroxine Sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Mylan Institutional Inc. | 42292-040 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-604 |
| Levothyroxine Sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-4377 |
| Levothyroxine Sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-4376 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1800 |
| Levothyroxine Sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-5362 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-5380 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-5381 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1803 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-5395 |
| Levothyroxine Sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1805 |
| Levothyroxine Sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1807 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1809 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-1811 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Mylan Institutional Inc. | 51079-442 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Mylan Institutional Inc. | 51079-440 |
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