Prescription drug · ANDA
Levothyroxine Sodium NDC 72189-107
Levothyroxine sodium .075 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-107-30 | 72189010730 | 30 TABLET in 1 BOTTLE (72189-107-30)Marketed from May 18, 2020 | |
| 72189-107-90 | 72189010790 | 90 TABLET in 1 BOTTLE (72189-107-90)Marketed from May 18, 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 — .075 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- DIRECT RX
- 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 72189-107_1922dbd9-96de-8652-e063-6294a90a0afeSPL ID 1922dbd9-96de-8652-e063-6294a90a0afeSPL set ID a5f15022-1166-09fe-e053-2a95a90aa218RxCUI 892246, 966220, 966221, 966222, 966224, 966225, 966248, 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
N472189010730followed by a unit qualifier and the quantityPackage 72189-0107-30. 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 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 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 patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce…
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 .025 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-985 |
| 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 |
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