Prescription drug · NDA
Lokelma (Sodium zirconium cyclosilicate) NDC 50090-6501
Sodium zirconium cyclosilicate 10 g/10g · Powder, For suspension · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6501-0 | 50090650100 | 30 PACKET in 1 BOX (50090-6501-0) / 10 g in 1 PACKETMarketed from May 25, 2023 | |
| 50090-6501-1 | 50090650101 | 3 PACKET in 1 BAG (50090-6501-1) / 10 g in 1 PACKETMarketed from Jun 7, 2023 |
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)
- Lokelma
- Generic name (nonproprietary)
- sodium zirconium cyclosilicate
- Active ingredients
- Sodium zirconium cyclosilicate — 10 g/10g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207078
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-6501_5bb5ae7d-0be6-4ecc-bb31-4eedd2f724b9SPL ID 5bb5ae7d-0be6-4ecc-bb31-4eedd2f724b9SPL set ID 8833d6e6-33ab-4ea9-b78f-3ec30a904ef8RxCUI 2047642, 2053927UNII D652ZWF066
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
N450090650100followed by a unit qualifier and the quantityPackage 50090-6501-00. 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)
LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14) ] . LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. ( 1 ) Limitation of Use LOKELMA 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 50090-6501
- What is NDC 50090-6501?
- 50090-6501 is the product NDC for Lokelma (sodium zirconium cyclosilicate), Sodium zirconium cyclosilicate 10 g/10g powder, for suspension, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lokelma (Sodium zirconium cyclosilicate).
- What is the active ingredient?
- Sodium zirconium cyclosilicate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lokelma?
- 3 other product NDCs are listed under this name. See all Lokelma NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lokelma products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 5 g/5g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1105 | 00310-1105-3000310-1105-39 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 10 g/10g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1110 | 00310-1110-3000310-1110-3900310-1110-93 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 5 g/5g | Powder, For suspensionOral | A-S Medication Solutions | 50090-6502 | 50090-6502-00 |
Other NDCs under NDA 207078
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 |
|---|---|---|---|---|
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 5 g/5g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1105 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 10 g/10g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1110 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 5 g/5g | Powder, For suspensionOral | A-S Medication Solutions | 50090-6502 |