What is NDC 43386-917?

43386-917 is the product NDC for Potassium Chloride, Potassium chloride 20 meq/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Potassium Chloride?

217 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Potassium Chloride NDC 43386-917 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-917Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0917Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
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.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206347
Marketing start: Jan 21, 2016
Listing expires: Dec 31, 2026
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

N443386091701 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Jan 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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. 1. 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.

Full label on DailyMed (opens in a new tab)

About NDC 43386-917

What is NDC 43386-917?: 43386-917 is the product NDC for Potassium Chloride, Potassium chloride 20 meq/1 tablet, extended release, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Potassium Chloride.
What is the active ingredient?: Potassium chloride.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Potassium Chloride?: 217 other product NDCs are listed under this name. See all Potassium Chloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Potassium Chloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Potassium Chloridepotassium chloride oral	Potassium chloride 1.5 g/15mL	SolutionOral	Cardinal Health 107, LLC	55154-8026	55154-8026-05
Potassium Chloride	Potassium chloride 1.5 g/1.58g	Powder, For solutionOral	Cardinal Health 107, LLC	55154-8352	55154-8352-05
Potassium Chloride	Potassium chloride 750 mg/1	Tablet, Film coated, Extended releaseOral	Coupler LLC	67046-1032	67046-1032-03
Potassium Chloride	Potassium chloride 750 mg/1	Tablet, Film coated, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-423	60760-0423-90
Potassium Chloride	Potassium chloride 750 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	82868-111	82868-0111-90
Potassium Chloride	Potassium chloride 20 meq/15mL	SolutionOral	Ajenat Pharmaceuticals LLC	82983-411	82983-0411-47
Potassium Chloride	Potassium chloride 40 meq/15mL	SolutionOral	Ajenat Pharmaceuticals LLC	82983-412	82983-0412-47
Potassium Chloride	Potassium chloride 20 meq/1	Tablet, Extended releaseOral	Major Pharmaceuticals	0904-7548	00904-7548-61
Potassium Chloride	Potassium chloride 3 g/3.16g	For solutionOral	IPG Pharmaceuticals, Inc.	71085-083	71085-0083-30
Potassium Chloride	Potassium chloride 20 meq/15mL	SolutionOral	Aurobindo Pharma Limited	59651-959	59651-0959-47

All 218 Potassium Chloride NDCs

Other NDCs under ANDA 206347

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206347
Product	Strength	Form · route	Labeler	Product NDC
Potassium Chloride	Potassium chloride 10 meq/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals,Inc.	43386-915