What is NDC 72189-223?

72189-223 is the product NDC for Montelukast Sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by DIRECT RX. It has 1 package NDC, 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 72189-223 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0223Add 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
72189-223-30	7218902233072189022330	30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30)Marketed from May 21, 2021

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: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204093
Marketing start: May 21, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 72189-223_2c283d75-2454-ee48-e063-6294a90a7651SPL ID 2c283d75-2454-ee48-e063-6294a90a7651SPL set ID c2d834e6-7b38-d266-e053-2995a90a27efRxCUI 242438UNII MHM278SD3E
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

N472189022330 followed by a unit qualifier and the quantity

Package 72189-0223-30. 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 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neurops…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-223

What is NDC 72189-223?: 72189-223 is the product NDC for Montelukast Sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by DIRECT RX. It has 1 package NDC, 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?: 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 sodium 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-418	72189-0418-3072189-0418-90
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 204093

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

FDA NDC Directory listings under ANDA 204093
Product	Strength	Form · route	Labeler	Product NDC
montelukast sodium	Montelukast 4 mg/1	Tablet, ChewableOral	Camber Pharmaceuticals, Inc.	31722-727
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	Camber Pharmaceuticals, Inc.	31722-728
montelukast sodium	Montelukast 4 mg/1	Tablet, ChewableOral	A-S Medication Solutions	50090-2921
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	A-S Medication Solutions	50090-4705
montelukast sodium	Montelukast 4 mg/1	Tablet, ChewableOral	A-S Medication Solutions	50090-7920
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	A-S Medication Solutions	50090-7925
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	Preferred Pharmaceuticals, Inc.	68788-7669
montelukast sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Bryant Ranch Prepack	71335-1602