What is NDC 42291-622?

42291-622 is the product NDC for Montelukast Sodium, Montelukast sodium 4 mg/1 tablet, chewable, listed with the FDA by AvKARE. It has 3 package NDCs, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-622 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0622Add 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
42291-622-10	4229106221042291062210	1000 TABLET, CHEWABLE in 1 BOTTLE (42291-622-10)Marketed from Aug 4, 2016
42291-622-30	4229106223042291062230	30 TABLET, CHEWABLE in 1 BOTTLE (42291-622-30)Marketed from Jan 4, 2013
42291-622-90	4229106229042291062290	90 TABLET, CHEWABLE in 1 BOTTLE (42291-622-90)Marketed from Jan 4, 2013

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 sodium — 4 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200405
Marketing start: Jan 4, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 42291-622_4617d4b7-780e-f9ce-e063-6294a90aa00bSPL ID 4617d4b7-780e-f9ce-e063-6294a90aa00bSPL set ID ed2caffa-a75c-1c27-ae30-2d8280eaea7dRxCUI 200224, 242438, 311759UNII U1O3J18SFLUPC 0342291623101, 0342291623309
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

N442291062210 followed by a unit qualifier and the quantity

Package 42291-0622-10. 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 16, 2025.

Indications (excerpt from the label)

Montelukast sodium tablets is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months of age and older (1.3) . 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-622

What is NDC 42291-622?: 42291-622 is the product NDC for Montelukast Sodium, Montelukast sodium 4 mg/1 tablet, chewable, listed with the FDA by AvKARE. It has 3 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 sodium.
Who is the labeler?: AvKARE, NDC labeler code 42291. 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 200405

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

FDA NDC Directory listings under ANDA 200405
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	AvKARE	42291-623
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	AvPAK	50268-573
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	AvPAK	50268-574
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Chartwell RX, LLC	62135-781
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Chartwell RX, LLC	62135-782
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Lannett Company, Inc.	62175-204
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Lannett Company, Inc.	62175-205
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Proficient Rx LP	63187-896
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Proficient Rx LP	71205-189