Prescription drug · ANDA
Potassium Chloride NDC 70771-1600
Potassium chloride 1500 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1600-0 | 70771160000 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1600-0)Marketed from Feb 3, 2022 | |
| 70771-1600-1 | 70771160001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1600-1)Marketed from Feb 3, 2022 | |
| 70771-1600-5 | 70771160005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1600-5)Marketed from Feb 3, 2022 |
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)
- Potassium Chloride
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 1500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210395
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1600_c6b38e40-cd5a-41ed-92d6-eb25e9c0c725SPL ID c6b38e40-cd5a-41ed-92d6-eb25e9c0c725SPL set ID 099c3a36-f460-4191-80e5-0c4153a5c713RxCUI 1801294, 1801298UNII 660YQ98I10UPC 0370771160013, 0370771159918
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
N470771160000followed by a unit qualifier and the quantityPackage 70771-1600-00. 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)
INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210395
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 |
|---|---|---|---|---|
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1599 |
| Potassium Chloride | Potassium chloride 1500 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-740 |
| Potassium Chloride | Potassium chloride 750 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-861 |