Prescription drug · NDA
levothyroxine sodium NDC 71335-1478
Levothyroxine sodium 100 ug/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1478-0 | 71335147800 | 1000 TABLET in 1 BOTTLE (71335-1478-0)Marketed from Jan 16, 2020 | |
| 71335-1478-1 | 71335147801 | 100 TABLET in 1 BOTTLE (71335-1478-1)Marketed from Jan 16, 2020 | |
| 71335-1478-2 | 71335147802 | 30 TABLET in 1 BOTTLE (71335-1478-2)Marketed from Jan 16, 2020 | |
| 71335-1478-3 | 71335147803 | 60 TABLET in 1 BOTTLE (71335-1478-3)Marketed from Jan 16, 2020 | |
| 71335-1478-4 | 71335147804 | 7 TABLET in 1 BOTTLE (71335-1478-4)Marketed from Jan 16, 2020 | |
| 71335-1478-5 | 71335147805 | 14 TABLET in 1 BOTTLE (71335-1478-5)Marketed from Jan 16, 2020 | |
| 71335-1478-6 | 71335147806 | 90 TABLET in 1 BOTTLE (71335-1478-6)Marketed from Jan 16, 2020 | |
| 71335-1478-7 | 71335147807 | 28 TABLET in 1 BOTTLE (71335-1478-7)Marketed from Jan 16, 2020 | |
| 71335-1478-8 | 71335147808 | 56 TABLET in 1 BOTTLE (71335-1478-8)Marketed from Jan 16, 2020 | |
| 71335-1478-9 | 71335147809 | 180 TABLET in 1 BOTTLE (71335-1478-9)Marketed from Jan 16, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021116
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 71335-1478_5dd258ee-53fd-4e60-b3c9-b3cfacd622bfSPL ID 5dd258ee-53fd-4e60-b3c9-b3cfacd622bfSPL set ID 9e3bffb9-f66e-4c73-befc-e60d769f6610RxCUI 892246, 892251, 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
N471335147800followed by a unit qualifier and the quantityPackage 71335-1478-00. 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 NDA 021116
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 | Proficient Rx LP | 71205-353 |
| levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1447 |
| levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Proficient Rx LP | 71205-354 |
| levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1423 |
| levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1435 |
| levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Proficient Rx LP | 71205-352 |
| levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1438 |
| levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Proficient Rx LP | 71205-351 |
| levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1456 |
| levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-1465 |
| levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Alvogen, Inc. | 47781-646 |
| levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Alvogen, Inc. | 47781-640 |
| levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Alvogen, Inc. | 47781-643 |
| levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Alvogen, Inc. | 47781-654 |
| Levothyroxine Sodium | Levothyroxine sodium 112 ug/1 | TabletOral | DIRECT RX | 72189-159 |
| levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Alvogen, Inc. | 47781-649 |
| Levothyroxine Sodium | Levothyroxine sodium 50 ug/1 | TabletOral | DIRECT RX | 72189-155 |
| levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Alvogen, Inc. | 47781-651 |
| levothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Alvogen, Inc. | 47781-662 |
| levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Alvogen, Inc. | 47781-657 |
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