Montelukast Sodium NDC 63187-692

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-692Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0692Add 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
63187-692-30	63187069230	30 TABLET, COATED in 1 BOTTLE (63187-692-30)Marketed from Apr 1, 2016
63187-692-60	63187069260	60 TABLET, COATED in 1 BOTTLE (63187-692-60)Marketed from Apr 1, 2016
63187-692-90	63187069290	90 TABLET, COATED in 1 BOTTLE (63187-692-90)Marketed from Apr 1, 2016

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 sodium
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203432
Marketing start: Nov 10, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554SPL ID 51ba5811-a7f6-4c07-abde-873a75ba5554SPL set ID 901385e5-7384-4c28-a36a-7dd84c36f5fdRxCUI 200224UNII 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

N463187069230 followed by a unit qualifier and the quantity

Package 63187-0692-30. 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 1, 2021.

Indications (excerpt from the label)

Montelukast sodium tablets, chewable tablets, and oral granules are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months of age and older ( 1.3 ). 1.1 Asthma Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203432

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

FDA NDC Directory listings under ANDA 203432
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, CoatedOral	Ajanta Pharma USA Inc.	27241-018