Montelukast Sodium (montelukast) NDC 65162-732

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-732Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0732Add 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
65162-732-03	65162073203	30 TABLET in 1 BOTTLE (65162-732-03)Marketed from Jul 31, 2013
65162-732-09	65162073209	90 TABLET in 1 BOTTLE (65162-732-09)Marketed from Jul 31, 2013
65162-732-11	65162073211	1000 TABLET in 1 BOTTLE (65162-732-11)Marketed from Jul 31, 2013

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204604
Marketing start: Jul 31, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-732_c2e9ec7d-8998-4a92-8394-5da85fb91fcfSPL ID c2e9ec7d-8998-4a92-8394-5da85fb91fcf
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

N465162073203 followed by a unit qualifier and the quantity

Package 65162-0732-03. 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

The FDA listing for this product does not reference a label (SPL) set.