Prescription drug · ANDA
Levothyroxine sodium NDC 0480-8693
Levothyroxine sodium 88 ug/1 · Tablet · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-8693-10 | 0048086931000480869310 | 1000 TABLET in 1 BOTTLE (0480-8693-10)Marketed from Sep 21, 2022 | |
| 0480-8693-98 | 0048086939800480869398 | 90 TABLET in 1 BOTTLE (0480-8693-98)Marketed from Sep 21, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 88 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207588
- Marketing start
- Marketing end
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 0480-8693_8f65417f-488f-4e4a-894c-56f99ed57d25SPL ID 8f65417f-488f-4e4a-894c-56f99ed57d25SPL set ID 60cadfd7-82b5-4207-97e1-1dd0655efb27RxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0304808704987, 0304808725982, 0304808690983, 0304808718984, 0304808715983, 0304808682988, 0304808693984
- 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
N400480869310followed by a unit qualifier and the quantityPackage 00480-8693-10. 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 0480-8693
- What is NDC 0480-8693?
- 0480-8693 is the product NDC for Levothyroxine sodium, Levothyroxine sodium 88 ug/1 tablet, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 2 package NDCs, 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?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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?
- 517 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 .05 mg/1 | TabletOral | Coupler LLC | 67046-0819 | 67046-0819-03 |
| 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 |
Other NDCs under ANDA 207588
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 | Teva Pharmaceuticals, Inc. | 0480-8690 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8704 |
| Levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8710 |
| Levothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8718 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-8722 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | A-S Medication Solutions | 50090-7526 |
| Levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | A-S Medication Solutions | 50090-7527 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | A-S Medication Solutions | 50090-7937 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8792 |
| Levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8902 |
| Levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2538 |
| Levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2562 |
| Levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Proficient Rx LP | 82804-149 |