Montelukast Sodium NDC 71335-0514

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0514Add 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
71335-0514-1	71335051401	30 TABLET, FILM COATED in 1 BOTTLE (71335-0514-1)Marketed from Mar 8, 2018
71335-0514-2	71335051402	4 TABLET, FILM COATED in 1 BOTTLE (71335-0514-2)Marketed from Dec 27, 2021
71335-0514-3	71335051403	7 TABLET, FILM COATED in 1 BOTTLE (71335-0514-3)Marketed from Dec 27, 2021
71335-0514-4	71335051404	60 TABLET, FILM COATED in 1 BOTTLE (71335-0514-4)Marketed from Aug 29, 2018
71335-0514-5	71335051405	10 TABLET, FILM COATED in 1 BOTTLE (71335-0514-5)Marketed from Dec 27, 2021
71335-0514-6	71335051406	90 TABLET, FILM COATED in 1 BOTTLE (71335-0514-6)Marketed from Feb 12, 2018
71335-0514-7	71335051407	120 TABLET, FILM COATED in 1 BOTTLE (71335-0514-7)Marketed from Apr 12, 2019
71335-0514-8	71335051408	15 TABLET, FILM COATED in 1 BOTTLE (71335-0514-8)Marketed from Dec 27, 2021

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: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202717
Marketing start: Apr 11, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-0514_dd8189d6-e479-4e78-812c-523db9c3bdaeSPL ID dd8189d6-e479-4e78-812c-523db9c3bdaeSPL set ID 4ba27278-6249-4546-9331-b19302cbf2dbRxCUI 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

N471335051401 followed by a unit qualifier and the quantity

Package 71335-0514-01. 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 Nov 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 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 tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202717

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

FDA NDC Directory listings under ANDA 202717
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3355
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-781
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4047
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-119
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-762
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1926