Prescription drug · ANDA
Levothyroxine Sodium NDC 51655-985
Levothyroxine sodium .025 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-985-52 | 51655098552 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-985-52)Marketed from May 4, 2022 |
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 — .025 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209713
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 51655-985_4a28800d-14f1-d841-e063-6394a90a692bSPL ID 4a28800d-14f1-d841-e063-6394a90a692bSPL set ID e0503b8c-7eb7-269e-e053-2995a90a1bcaRxCUI 966220UNII 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
N451655098552followed by a unit qualifier and the quantityPackage 51655-0985-52. 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 209713
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 .137 mg/1 | TabletOral | American Health Packaging | 60687-563 |
| Levothyroxine Sodium | Levothyroxine sodium .175 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6957 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | American Health Packaging | 60687-486 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-483 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | American Health Packaging | 60687-497 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6954 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-479 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | American Health Packaging | 60687-508 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-484 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-485 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-989 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3558 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6955 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | American Health Packaging | 60687-519 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3116 |
| Levothyroxine Sodium | Levothyroxine sodium .175 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8793 |
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3559 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3560 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Coupler LLC | 67046-0290 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | DIRECT RX | 72189-107 |
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