What is NDC 33342-111?

33342-111 is the product NDC for Montelukast sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by Macleods Pharmaceuticals Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Montelukast sodium?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Montelukast sodium NDC 33342-111 | National Drug Code

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	3334201110733342011107	30 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07)Marketed from Mar 13, 2015
33342-111-10	3334201111033342011110	90 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10)Marketed from Mar 13, 2015
33342-111-12	3334201111233342011112	100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12)Marketed from Mar 13, 2015
33342-111-15	3334201111533342011115	500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15)Marketed from Mar 13, 2015
33342-111-39	3334201113933342011139	90 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39)Marketed from Mar 13, 2015
33342-111-44	3334201114433342011144	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 LimitedNDC labeler code 33342
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)

About NDC 33342-111

What is NDC 33342-111?: 33342-111 is the product NDC for Montelukast sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by Macleods Pharmaceuticals Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Montelukast sodium.
What is the active ingredient?: Montelukast.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Montelukast sodium?: 70 other product NDCs are listed under this name. See all Montelukast sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Montelukast sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4753	70518-4753-00
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8617	68788-8617-0368788-8617-0668788-8617-09
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8610	68788-8610-0368788-8610-0668788-8610-09
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-100	16571-0100-0916571-0100-10
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-418	72189-0418-3072189-0418-90
Montelukast Sodium	Montelukast 5 mg/1	Tablet, ChewableOral	DIRECT RX	72189-223	72189-0223-30
Montelukast Sodiummontelukast	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Amneal Pharmaceuticals LLC	65162-771	65162-0771-03
Montelukast Sodiummontelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Amneal Pharmaceuticals LLC	65162-772	65162-0772-03
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	Preferred Pharmaceuticals, Inc.	68788-7669	68788-7669-0168788-7669-0268788-7669-03+3 more
Montelukast Sodium	Montelukast sodium 4 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-329	59651-0329-30

All 71 Montelukast sodium NDCs

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