NDC 0310-1105
LOKELMA
Sodium Zirconium Cyclosilicate
LOKELMA is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Sodium Zirconium Cyclosilicate.
| Product ID | 0310-1105_2ba30e76-7e86-4c7d-a1ea-1ed04f7984e5 |
| NDC | 0310-1105 |
| Product Type | Human Prescription Drug |
| Proprietary Name | LOKELMA |
| Generic Name | Sodium Zirconium Cyclosilicate |
| Dosage Form | Powder, For Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-09-04 |
| Marketing Category | NDA / NDA |
| Application Number | NDA207078 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | SODIUM ZIRCONIUM CYCLOSILICATE |
| Active Ingredient Strength | 5 g/5g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0310-1105-30
30 PACKET in 1 BOX (0310-1105-30) > 5 g in 1 PACKET (0310-1105-01)
| Marketing Start Date | 2018-09-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0310-1105-30 [00310110530]
LOKELMA POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA207078 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-04 |
NDC 0310-1105-01 [00310110501]
LOKELMA POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA207078 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-09-04 |
NDC 0310-1105-39 [00310110539]
LOKELMA POWDER, FOR SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA207078 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-01-02 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM ZIRCONIUM CYCLOSILICATE | 5 g/5g |
OpenFDA Data
| SPL SET ID: | 90bf8e28-748d-4e4b-a19f-9cf483370eff |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "LOKELMA" or generic name "Sodium Zirconium Cyclosilicate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate |
Trademark Results [LOKELMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOKELMA 87936350 5723751 Live/Registered |
ZS Pharma, Inc. 2018-05-25 |
 LOKELMA 87604023 5728779 Live/Registered |
ZS Pharma, Inc. 2017-09-11 |
 LOKELMA 86240215 not registered Dead/Abandoned |
ZS PHARMA, INC. 2014-04-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.