Prescription drug · NDA
Veltassa (Patiromer) NDC 53436-252
Patiromer 25.2 g/1 · Powder, For suspension · Oral · Vifor Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53436-252-30 | 53436025230 | 30 PACKET in 1 CARTON (53436-252-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-252-01)Marketed from Oct 23, 2015 |
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)
- Veltassa
- Generic name (nonproprietary)
- patiromer
- Active ingredients
- Patiromer — 25.2 g/1
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Vifor Pharma, Inc.NDC labeler code 53436
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205739
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 53436-252_3e4b6452-1c7c-4f58-aee4-12fb185aaa83SPL ID 3e4b6452-1c7c-4f58-aee4-12fb185aaa83SPL set ID bf002984-d6c9-46df-aecb-a07733f763c1RxCUI 1716209, 1716215, 1716217, 1716219, 1716221, 1716223, 2692050, 2692052UNII 1FQ2RY5YHH
- Pharmacologic class
- Potassium Binder
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
N453436025230followed by a unit qualifier and the quantityPackage 53436-0252-30. 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)
Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) ] . Veltassa is a potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. ( 1 ) Limitation of Use Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 53436-252
- What is NDC 53436-252?
- 53436-252 is the product NDC for Veltassa (patiromer), Patiromer 25.2 g/1 powder, for suspension, listed with the FDA by Vifor Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Veltassa (Patiromer).
- What is the active ingredient?
- Patiromer.
- Who is the labeler?
- Vifor Pharma, Inc., NDC labeler code 53436. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Veltassa?
- 3 other product NDCs are listed under this name. See all Veltassa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Veltassa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Veltassapatiromer | Patiromer 1 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-010 | 53436-0010-60 |
| Veltassapatiromer | Patiromer 8.4 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-084 | 53436-0084-0453436-0084-3053436-0084-92 |
| Veltassapatiromer | Patiromer 16.8 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-168 | 53436-0168-30 |
Other NDCs under NDA 205739
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 |
|---|---|---|---|---|
| Veltassapatiromer | Patiromer 1 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-010 |
| Veltassapatiromer | Patiromer 8.4 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-084 |
| Veltassapatiromer | Patiromer 16.8 g/1 | Powder, For suspensionOral | Vifor Pharma, Inc. | 53436-168 |