Prescription drug · NDA
Lokelma (Sodium zirconium cyclosilicate) NDC 0310-1105
Sodium zirconium cyclosilicate 5 g/5g · Powder, For suspension · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-1105-30 | 00310110530 | 30 PACKET in 1 BOX (0310-1105-30) / 5 g in 1 PACKET (0310-1105-01)Marketed from Sep 4, 2018 | |
| 0310-1105-39 | 00310110539 | 11 PACKET in 1 BOX (0310-1105-39) / 5 g in 1 PACKET (0310-1105-01)Marketed from Jan 2, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Lokelma
- Generic name (nonproprietary)
- sodium zirconium cyclosilicate
- Active ingredients
- Sodium zirconium cyclosilicate — 5 g/5g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207078
- Marketing start
- Listing expires
- Identifiers
- Product ID 0310-1105_e97b97a9-6ad1-4b47-a5be-fefd7be47c23SPL ID e97b97a9-6ad1-4b47-a5be-fefd7be47c23SPL set ID 90bf8e28-748d-4e4b-a19f-9cf483370effRxCUI 2047633, 2047639, 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
N400310110530followed by a unit qualifier and the quantityPackage 00310-1105-30. 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)
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 0310-1105
- What is NDC 0310-1105?
- 0310-1105 is the product NDC for Lokelma (sodium zirconium cyclosilicate), Sodium zirconium cyclosilicate 5 g/5g powder, for suspension, listed with the FDA by AstraZeneca Pharmaceuticals LP. 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?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. 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 10 g/10g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1110 | 00310-1110-3000310-1110-3900310-1110-93 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 10 g/10g | Powder, For suspensionOral | A-S Medication Solutions | 50090-6501 | 50090-6501-0050090-6501-01 |
| 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 10 g/10g | Powder, For suspensionOral | AstraZeneca Pharmaceuticals LP | 0310-1110 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 10 g/10g | Powder, For suspensionOral | A-S Medication Solutions | 50090-6501 |
| Lokelmasodium zirconium cyclosilicate | Sodium zirconium cyclosilicate 5 g/5g | Powder, For suspensionOral | A-S Medication Solutions | 50090-6502 |