Prescription drug · NDA
Rezdiffra (Resmetirom) NDC 82576-080
Resmetirom 80 mg/1 · Tablet, Coated · Oral · Madrigal Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82576-080-30 | 82576008030 | 30 TABLET, COATED in 1 BOTTLE (82576-080-30)Marketed from Mar 14, 2024 | |
| 82576-080-90 | 82576008090 | 90 TABLET, COATED in 1 BOTTLE (82576-080-90)Marketed from Mar 14, 2024 |
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)
- Rezdiffra
- Generic name (nonproprietary)
- resmetirom
- Active ingredients
- Resmetirom — 80 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Madrigal Pharmaceuticals, Inc.NDC labeler code 82576
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217785
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Thyroid Hormone Receptor beta Agonists (Mechanism)
- Identifiers
- Product ID 82576-080_1fec1a4b-28d9-41c3-ae32-59b53cd41f07SPL ID 1fec1a4b-28d9-41c3-ae32-59b53cd41f07SPL set ID e67ea09f-a840-439c-86c8-f98585f978b2RxCUI 2677899, 2677905, 2677907, 2677909, 2677911, 2677913UNII RE0V0T1ES0UPC 0382576060306
- Pharmacologic class
- Thyroid Hormone Receptor beta Agonist
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
N482576008030followed by a unit qualifier and the quantityPackage 82576-0080-30. 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 .
Indications (excerpt from the label)
REZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7) , Clinica…
Excerpt only. Read the full label for complete information.
About NDC 82576-080
- What is NDC 82576-080?
- 82576-080 is the product NDC for Rezdiffra (resmetirom), Resmetirom 80 mg/1 tablet, coated, listed with the FDA by Madrigal Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rezdiffra (Resmetirom).
- What is the active ingredient?
- Resmetirom.
- Who is the labeler?
- Madrigal Pharmaceuticals, Inc., NDC labeler code 82576. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rezdiffra?
- 2 other product NDCs are listed under this name. See all Rezdiffra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rezdiffra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rezdiffraresmetirom | Resmetirom 60 mg/1 | Tablet, CoatedOral | Madrigal Pharmaceuticals, Inc. | 82576-060 | 82576-0060-30 |
| Rezdiffraresmetirom | Resmetirom 100 mg/1 | Tablet, CoatedOral | Madrigal Pharmaceuticals, Inc. | 82576-100 | 82576-0100-3082576-0100-90 |
Other NDCs under NDA 217785
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 |
|---|---|---|---|---|
| Rezdiffraresmetirom | Resmetirom 60 mg/1 | Tablet, CoatedOral | Madrigal Pharmaceuticals, Inc. | 82576-060 |
| Rezdiffraresmetirom | Resmetirom 100 mg/1 | Tablet, CoatedOral | Madrigal Pharmaceuticals, Inc. | 82576-100 |