What is NDC 33342-102?

33342-102 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 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?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Montelukast NDC 33342-102 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-102Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0102Add 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
33342-102-07	3334201020733342010207	30 TABLET in 1 BOTTLE (33342-102-07)Marketed from Sep 11, 2014
33342-102-10	3334201021033342010210	90 TABLET in 1 BOTTLE (33342-102-10)Marketed from Sep 11, 2014
33342-102-12	3334201021233342010212	100 TABLET in 1 BLISTER PACK (33342-102-12)Marketed from Sep 11, 2014
33342-102-15	3334201021533342010215	500 TABLET in 1 BOTTLE (33342-102-15)Marketed from Sep 11, 2014
33342-102-39	3334201023933342010239	90 TABLET in 1 BLISTER PACK (33342-102-39)Marketed from Sep 11, 2014

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
Generic name (nonproprietary): montelukast
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203366
Marketing start: Sep 11, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6SPL ID c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6SPL set ID e0c5b856-3f70-4ca6-9763-a90673bb82fbRxCUI 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

N433342010207 followed by a unit qualifier and the quantity

Package 33342-0102-07. 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 Jan 21, 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 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium tablets are i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-102

What is NDC 33342-102?: 33342-102 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Montelukast.
What is the active ingredient?: Montelukast sodium.
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?: 15 other product NDCs are listed under this name. See all Montelukast 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Coupler LLC	67046-2060	67046-2060-03
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-009	82009-0009-10
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-556	50268-0556-15
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8099	68788-8099-0368788-8099-0668788-8099-09
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3133	70518-3133-0070518-3133-0170518-3133-02
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-563	71610-0563-30
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-175	72865-0175-1072865-0175-3072865-0175-90
Montelukast	Montelukast sodium 10 mg/1	TabletOral	BluePoint Laboratories	68001-361	68001-0361-0368001-0361-0468001-0361-05
Montelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Proficient Rx LP	63187-626	63187-0626-3063187-0626-6063187-0626-90
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3855	68071-3855-03

All 16 Montelukast NDCs

Other NDCs under ANDA 203366

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

FDA NDC Directory listings under ANDA 203366
Product	Strength	Form · route	Labeler	Product NDC
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Coupler LLC	67046-2060
Montelukast	Montelukast sodium 10 mg/1	TabletOral	BluePoint Laboratories	68001-361
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3855
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4034