montelukast sodium NDC 68071-5278

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-5278Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-5278Add 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
68071-5278-3	68071527803	30 TABLET, FILM COATED in 1 BOTTLE (68071-5278-3)Marketed from Jun 10, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204290
Marketing start: Jan 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68071-5278_2a80536c-27fd-0142-e063-6294a90a458fSPL ID 2a80536c-27fd-0142-e063-6294a90a458fSPL set ID a7c11cbe-0834-27a5-e053-2995a90ac43fRxCUI 200224UNII U1O3J18SFLUPC 0368071527834
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

N468071527803 followed by a unit qualifier and the quantity

Package 68071-5278-03. 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 Dec 30, 2024. 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 ). 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 y…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204290

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

FDA NDC Directory listings under ANDA 204290
Product	Strength	Form · route	Labeler	Product NDC
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1995
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-220
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8617
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-181