What is NDC 72189-418?

72189-418 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 72189-418 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-418Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0418Add 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	Copy
72189-418-30	7218904183072189041830	30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30)Marketed from Feb 2, 2023
72189-418-90	7218904189072189041890	90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90)Marketed from Feb 2, 2023

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202843
Marketing start: Feb 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 72189-418_2c4d0d3f-0096-e010-e063-6294a90a1ae9SPL ID 2c4d0d3f-0096-e010-e063-6294a90a1ae9SPL set ID f3bdf2a3-d661-5128-e053-2995a90a4661RxCUI 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

N472189041830 followed by a unit qualifier and the quantity

Package 72189-0418-30. 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 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. 1.3 Allergic Rhinitis tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with reserve use for patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-418

What is NDC 72189-418?: 72189-418 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 2 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?: Direct_Rx, NDC labeler code 72189. 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 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
montelukast sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Unichem Pharmaceuticals (USA), Inc.	29300-221	29300-0221-1029300-0221-1329300-0221-19

All 71 Montelukast Sodium NDCs

Other NDCs under ANDA 202843

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

FDA NDC Directory listings under ANDA 202843
Product	Strength	Form · route	Labeler	Product NDC
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1979
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-009
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-175
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8099
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-8075
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3133
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-556
Montelukastmontelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6109
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6108
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-726
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-563
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6808