Montelukast Sodium (montelukast) NDC 65162-771

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-771Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0771Add 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
65162-771-03	65162077103	30 TABLET, CHEWABLE in 1 BOTTLE (65162-771-03)Marketed from Sep 4, 2020

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): Montelukast Sodium
Generic name (nonproprietary): montelukast
Active ingredients: Montelukast sodium — 4 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205107
Marketing start: Sep 4, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-771_ed8a8093-3cde-44cf-9bdc-c8bc5fb9909cSPL ID ed8a8093-3cde-44cf-9bdc-c8bc5fb9909cSPL set ID bcd49102-a21c-4628-a322-6cdd934e7f09RxCUI 242438, 311759UNII U1O3J18SFL
Pharmacologic class: Leukotriene Receptor Antagonist

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

N465162077103 followed by a unit qualifier and the quantity

Package 65162-0771-03. 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 18, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older. (1.1) Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. (1.2) Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies. (1.3) Limitations of Use: Not indicated to treat an acute asthma attack. (5.2) 1.1 Asthma Montelukast sodium chewable tablets …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205107

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

FDA NDC Directory listings under ANDA 205107
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodiummontelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Amneal Pharmaceuticals LLC	65162-772