Prescription drug · ANDA
Levothyroxine sodium NDC 16729-448
Levothyroxine sodium 50 ug/1 · Tablet · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-448-15 | 16729044815 | 90 TABLET in 1 BOTTLE (16729-448-15)Marketed from Dec 3, 2020 | |
| 16729-448-17 | 16729044817 | 1000 TABLET in 1 BOTTLE (16729-448-17)Marketed from Nov 25, 2020 |
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
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212399
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 16729-448_415fc774-31a5-124f-e063-6294a90a0e46SPL ID 415fc774-31a5-124f-e063-6294a90a0e46SPL set ID a6233381-3043-4e9a-aaa6-a6b105e5142bRxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0316729447157, 0316729449151, 0316729452151, 0316729454155, 0316729453158, 0316729448154, 0316729451154, 0316729457156, 0316729450157, 0316729456159, 0316729458153, 0316729455152
- 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
N416729044815followed by a unit qualifier and the quantityPackage 16729-0448-15. 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 212399
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 50 ug/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-272 |
| Levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-297 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2090 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3619 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | REMEDYREPACK INC. | 70518-3154 |
| Levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Proficient Rx LP | 71205-646 |
| Levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | REMEDYREPACK INC. | 70518-3208 |
| Levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Proficient Rx LP | 82804-168 |
| Levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2138 |
| Levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1861 |
| Levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-447 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-452 |
| Levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1881 |
| Levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-449 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-450 |
| Levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | REMEDYREPACK INC. | 70518-3274 |
| Levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-451 |
| Levothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-455 |
| Levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Proficient Rx LP | 71205-681 |
| Levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Accord Healthcare Inc. | 16729-453 |
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