Montelukast Sodium NDC 71205-778

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-778Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0778Add 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
71205-778-30	71205077830	30 TABLET, FILM COATED in 1 BOTTLE (71205-778-30)Marketed from Mar 21, 2023
71205-778-60	71205077860	60 TABLET, FILM COATED in 1 BOTTLE (71205-778-60)Marketed from Mar 21, 2023
71205-778-90	71205077890	90 TABLET, FILM COATED in 1 BOTTLE (71205-778-90)Marketed from Mar 21, 2023

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, Film coated
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202468
Marketing start: Aug 3, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 71205-778_461f2aaa-e091-478e-97c1-27a089db8cdcSPL ID 461f2aaa-e091-478e-97c1-27a089db8cdcSPL set ID 461f2aaa-e091-478e-97c1-27a089db8cdcRxCUI 200224UNII U1O3J18SFLUPC 0371205778309
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

N471205077830 followed by a unit qualifier and the quantity

Package 71205-0778-30. 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 Mar 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium is 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 is indicated for t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202468

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

FDA NDC Directory listings under ANDA 202468
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-255
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-306
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-574