Prescription drug · ANDA
Levothyroxine Sodium NDC 72865-238
Levothyroxine sodium .075 mg/1 · Tablet · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-238-10 | 72865023810 | 1000 TABLET in 1 BOTTLE (72865-238-10)Marketed from Jan 18, 2023 | |
| 72865-238-90 | 72865023890 | 90 TABLET in 1 BOTTLE (72865-238-90)Marketed from Jan 18, 2023 |
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
- XLCare Pharmaceuticals, Inc.NDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215259
- Marketing start
- Listing expires
- Other FDA classes
- Thyroxine (Chemical structure)
- Identifiers
- Product ID 72865-238_16376b6d-2936-4208-ab94-3e0969dce769SPL ID 16376b6d-2936-4208-ab94-3e0969dce769SPL set ID 51a27110-e787-409b-98ba-c6471d0ad5cfRxCUI 892246, 892251, 892255, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270UNII 9J765S329GUPC 0372865240106, 0372865242100, 0372865243107, 0372865241103, 0372865246108, 0372865245101, 0372865244104, 0372865237106, 0372865237908, 0372865247105, 0372865236109, 0372865239100, 0372865238905, 0372865238103
- 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
N472865023810followed by a unit qualifier and the quantityPackage 72865-0238-10. 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 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.
About NDC 72865-238
- What is NDC 72865-238?
- 72865-238 is the product NDC for Levothyroxine Sodium, Levothyroxine sodium .075 mg/1 tablet, listed with the FDA by XLCare 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?
- XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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 .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 .1 mg/1 | TabletOral | Coupler LLC | 67046-0569 | 67046-0569-03 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Coupler LLC | 67046-0515 | 67046-0515-03 |
| Levothyroxine Sodium | Levothyroxine sodium .075 mg/1 | TabletOral | Coupler LLC | 67046-0801 | 67046-0801-03 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Coupler LLC | 67046-0828 | 67046-0828-03 |
Other NDCs under ANDA 215259
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 .075 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-286 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-284 |
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-285 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-290 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-287 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-288 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-289 |
| Levothyroxine Sodium | Levothyroxine sodium .2 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-294 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-291 |
| Levothyroxine Sodium | Levothyroxine sodium .15 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-292 |
| Levothyroxine Sodium | Levothyroxine sodium .175 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-293 |
| Levothyroxine Sodium | Levothyroxine sodium .3 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-295 |
| Levothyroxine Sodium | Levothyroxine sodium .025 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-236 |
| Levothyroxine Sodium | Levothyroxine sodium .1 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-240 |
| Levothyroxine Sodium | Levothyroxine sodium .05 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-237 |
| Levothyroxine Sodium | Levothyroxine sodium .088 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-239 |
| Levothyroxine Sodium | Levothyroxine sodium .137 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-243 |
| Levothyroxine Sodium | Levothyroxine sodium .112 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-241 |
| Levothyroxine Sodium | Levothyroxine sodium .125 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-242 |
| Levothyroxine Sodium | Levothyroxine sodium .3 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-247 |
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