Prescription drug · ANDA
Potassium Chloride NDC 43386-917
Potassium chloride 20 meq/1 · Tablet, Extended release · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-917-01 | 43386091701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-01)Marketed from Jan 21, 2016 | |
| 43386-917-05 | 43386091705 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-05)Marketed from Jan 30, 2017 | |
| 43386-917-10 | 43386091710 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-917-10)Marketed from Jan 30, 2017 |
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)
- Potassium Chloride
- Generic name (nonproprietary)
- potassium chloride
- Active ingredients
- Potassium chloride — 20 meq/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206347
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 43386-917_a056d531-3e7b-4598-a042-0d498456be72SPL ID a056d531-3e7b-4598-a042-0d498456be72SPL set ID fe08221d-74d5-490a-8db4-eaf3ed20b289RxCUI 1801294, 1801298UNII 660YQ98I10
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
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
N443386091701followed by a unit qualifier and the quantityPackage 43386-0917-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 206347
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 10 meq/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals,Inc. | 43386-915 |