Montelukast sodium NDC 33342-111

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-111Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0111Add 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
33342-111-07	33342011107	30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07)Marketed from Mar 13, 2015
33342-111-10	33342011110	90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10)Marketed from Mar 13, 2015
33342-111-12	33342011112	100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12)Marketed from Mar 13, 2015
33342-111-15	33342011115	500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15)Marketed from Mar 13, 2015
33342-111-39	33342011139	90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39)Marketed from Mar 13, 2015
33342-111-44	33342011144	1000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44)Marketed from Sep 25, 2015

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 — 5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203582
Marketing start: Mar 13, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 33342-111_a12af8c6-41af-4850-b725-4f8226b35b67SPL ID a12af8c6-41af-4850-b725-4f8226b35b67SPL set ID ce512844-5220-4661-809f-56d088699c9cRxCUI 242438, 311759UNII MHM278SD3EUPC 0333342110077, 0333342111074
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

N433342011107 followed by a unit qualifier and the quantity

Package 33342-0111-07. 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 Jul 6, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium chewable tablet 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 chewable t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203582

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

FDA NDC Directory listings under ANDA 203582
Product	Strength	Form · route	Labeler	Product NDC
Montelukast sodium	Montelukast 4 mg/1	Tablet, ChewableOral	Macleods Pharmaceuticals Limited	33342-110