What is NDC 0378-4561?

0378-4561 is the product NDC for Potassium Chloride, Potassium chloride 10 meq/1 tablet, film coated, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?

216 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 0378-4561 | National Drug Code

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	0037845610500378456105	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05)Marketed from Nov 9, 2016
0378-4561-77	0037845617700378456177	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.NDC labeler code 0378
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)

About NDC 0378-4561

What is NDC 0378-4561?: 0378-4561 is the product NDC for Potassium Chloride, Potassium chloride 10 meq/1 tablet, film coated, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?: 216 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 Chloride	Potassium chloride 20 meq/1	Tablet, Extended releaseOral	Cardinal Health 107, LLC	55154-0586	55154-0586-00
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

All 217 Potassium Chloride NDCs

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 8 meq/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-4560
Potassium Chloride	Potassium chloride 10 meq/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6635