Prescription drug · NDA
levothyroxine sodium NDC 68071-5235
Levothyroxine sodium 100 ug/1 · Tablet · Oral · NuCar Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5235-9 | 68071523509 | 90 TABLET in 1 BOTTLE (68071-5235-9)Marketed from Mar 30, 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
- NuCar Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-5235_1b593159-b796-10ad-e063-6294a90abd25SPL ID 1b593159-b796-10ad-e063-6294a90abd25SPL set ID a2194c58-b755-e6b5-e053-2a95a90a36d4RxCUI 892246UNII 9J765S329GUPC 0368071523591
- 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
N468071523509followed by a unit qualifier and the quantityPackage 68071-5235-09. 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)
Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. ( 1 ) Limitations of Use: - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Hypothyroidism Levothyroxine Sodium …
Excerpt only. Read the full label for complete information.
About NDC 68071-5235
- What is NDC 68071-5235?
- 68071-5235 is the product NDC for levothyroxine sodium, Levothyroxine sodium 100 ug/1 tablet, listed with the FDA by NuCar Pharmaceuticals,Inc.. 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?
- NuCar Pharmaceuticals,Inc., NDC labeler code 68071. 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?
- 521 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 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 25 ug/1 | TabletOral | Alvogen, Inc. | 47781-640 |
| levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Alvogen, Inc. | 47781-643 |
| levothyroxine sodium | Levothyroxine sodium 75 ug/1 | TabletOral | Alvogen, Inc. | 47781-646 |
| levothyroxine sodium | Levothyroxine sodium 88 ug/1 | TabletOral | Alvogen, Inc. | 47781-649 |
| levothyroxine sodium | Levothyroxine sodium 100 ug/1 | TabletOral | Alvogen, Inc. | 47781-651 |
| levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Alvogen, Inc. | 47781-654 |
| levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | Alvogen, Inc. | 47781-657 |
| levothyroxine sodium | Levothyroxine sodium 137 ug/1 | TabletOral | Alvogen, Inc. | 47781-659 |
| levothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Alvogen, Inc. | 47781-662 |
| levothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Alvogen, Inc. | 47781-665 |
| levothyroxine sodium | Levothyroxine sodium 200 ug/1 | TabletOral | Alvogen, Inc. | 47781-668 |
| levothyroxine sodium | Levothyroxine sodium 300 ug/1 | TabletOral | Alvogen, Inc. | 47781-671 |
| levothyroxine sodium | Levothyroxine sodium 112 ug/1 | TabletOral | Alvogen, Inc. | 47781-721 |
| levothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Alvogen, Inc. | 47781-728 |
| levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | A-S Medication Solutions | 50090-4799 |
| levothyroxine sodium | Levothyroxine sodium 125 ug/1 | TabletOral | A-S Medication Solutions | 50090-7862 |
| levothyroxine sodium | Levothyroxine sodium 175 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-714 |
| levothyroxine sodium | Levothyroxine sodium 50 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-723 |
| levothyroxine sodium | Levothyroxine sodium 150 ug/1 | TabletOral | Northwind Health Company, LLC | 51655-727 |
| levothyroxine sodium | Levothyroxine sodium 25 ug/1 | TabletOral | Bryant Ranch Prepack | 63629-8711 |
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