Prescription drug · ANDA
Levothyroxine Sodium NDC 67046-0819
Levothyroxine sodium .05 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0819-3 | 67046081903 | 30 TABLET in 1 BLISTER PACK (67046-0819-3)Marketed from Jul 6, 2026 |
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 — .05 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-0819_55f4b986-a31c-23da-e063-6394a90a0b58SPL ID 55f4b986-a31c-23da-e063-6394a90a0b58SPL set ID 55f4c679-86cb-b97f-e063-6294a90ad5efRxCUI 966221UNII 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
N467046081903followed by a unit qualifier and the quantityPackage 67046-0819-03. 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.
About NDC 67046-0819
- What is NDC 67046-0819?
- 67046-0819 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .05 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levothyroxine Sodium.
- What is the active ingredient?
- Levothyroxine sodium.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levothyroxine Sodium?
- 528 other product NDCs are listed under this name. See all Levothyroxine Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levothyroxine Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | Coupler LLC | 67046-0972 | 67046-0972-03 |
| Levothyroxine Sodium | Levothyroxine sodium .2 mg/1 | TabletOral | Coupler LLC | 67046-0387 | 67046-0387-03 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | Coupler LLC | 67046-0951 | 67046-0951-03 |
| Levothyroxine Sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Coupler LLC | 67046-1679 | 67046-1679-03 |
| Levothyroxine Sodium | Levothyroxine sodium .175 mg/1 | TabletOral | Coupler LLC | 67046-0517 | 67046-0517-03 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Coupler LLC | 67046-0515 | 67046-0515-03 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Coupler LLC | 67046-0569 | 67046-0569-03 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Coupler LLC | 67046-0801 | 67046-0801-03 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Coupler LLC | 67046-0290 | 67046-0290-03 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Coupler LLC | 67046-0828 | 67046-0828-03 |
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 .1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3717 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Coupler LLC | 67046-0569 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | A-S Medication Solutions | 50090-6825 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | A-S Medication Solutions | 50090-6824 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6949 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | NuCarePharmaceuticals, Inc. | 68071-3692 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Proficient Rx LP | 82804-277 |
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6950 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | Proficient Rx LP | 82804-281 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3956 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Proficient Rx LP | 82804-290 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6951 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8896 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6952 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3730 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Coupler LLC | 67046-0801 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Coupler LLC | 67046-0828 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6953 |
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | Proficient Rx LP | 82804-314 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | A-S Medication Solutions | 50090-7767 |
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