Montelukast Sodium NDC 63187-751

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-751Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0751Add 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
63187-751-30	63187075130	30 TABLET, CHEWABLE in 1 BOTTLE (63187-751-30)Marketed from Oct 3, 2016
63187-751-60	63187075160	60 TABLET, CHEWABLE in 1 BOTTLE (63187-751-60)Marketed from Oct 3, 2016
63187-751-90	63187075190	90 TABLET, CHEWABLE in 1 BOTTLE (63187-751-90)Marketed from Oct 3, 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 — 4 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203328
Marketing start: Nov 10, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 63187-751_8bfb3767-f8fe-4bc4-8f45-1e84914d51f0SPL ID 8bfb3767-f8fe-4bc4-8f45-1e84914d51f0SPL set ID 54014b67-3163-4c8f-b93a-229cd231ca6bRxCUI 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

N463187075130 followed by a unit qualifier and the quantity

Package 63187-0751-30. 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 203328

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

FDA NDC Directory listings under ANDA 203328
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Ajanta Pharma USA Inc.	27241-016
Montelukast Sodiummontelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Ajanta Pharma USA Inc.	27241-017
Montelukast Sodiummontelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Proficient Rx LP	71205-128