Potassium Chloride NDC 0378-4561

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4561Add 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	Copy
0378-4561-05	00378456105	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05)Marketed from Nov 9, 2016
0378-4561-77	00378456177	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-77)Marketed from Nov 9, 2016

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): Potassium Chloride
Generic name (nonproprietary): potassium chloride
Active ingredients: Potassium chloride — 10 meq/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204662
Marketing start: Nov 9, 2016
Marketing end: Jan 31, 2027
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 0378-4561_a05e4397-8442-41d9-afa7-832163c3b554SPL ID a05e4397-8442-41d9-afa7-832163c3b554SPL set ID c64ed4c0-1e27-42b3-9625-fb4e0d31e271RxCUI 312529, 628953UNII 660YQ98I10UPC 0303784561775, 0303784560778
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

N400378456105 followed by a unit qualifier and the quantity

Package 00378-4561-05. 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 Apr 15, 2020.

Indications (excerpt from the label)

Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release tablets are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204662

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

FDA NDC Directory listings under ANDA 204662
Product	Strength	Form · route	Labeler	Product NDC
Potassium Chloride	Potassium chloride 10 meq/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6635
Potassium Chloride	Potassium chloride 8 meq/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-4560