What is NDC 31722-728?

31722-728 is the product NDC for montelukast sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 31722-728 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-728Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0728Add 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
31722-728-01	3172207280131722072801	100 TABLET, CHEWABLE in 1 BOTTLE (31722-728-01)Marketed from May 27, 2015
31722-728-10	3172207281031722072810	1000 TABLET, CHEWABLE in 1 BOTTLE (31722-728-10)Marketed from May 27, 2015
31722-728-30	3172207283031722072830	30 TABLET, CHEWABLE in 1 BOTTLE (31722-728-30)Marketed from May 27, 2015
31722-728-31	3172207283131722072831	10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-728-31)Marketed from May 27, 2015
31722-728-32	3172207283231722072832	100 TABLET, CHEWABLE in 1 CARTON (31722-728-32)Marketed from May 27, 2015
31722-728-90	3172207289031722072890	90 TABLET, CHEWABLE in 1 BOTTLE (31722-728-90)Marketed from May 27, 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: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204093
Marketing start: May 27, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 31722-728_c503ea71-c663-3cfc-e053-2a95a90a9aaaSPL ID c503ea71-c663-3cfc-e053-2a95a90a9aaaSPL set ID 23964723-2df8-4d0a-a53d-8538469672f1RxCUI 242438, 311759UNII MHM278SD3EUPC 0331722727303, 0331722728300
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

N431722072801 followed by a unit qualifier and the quantity

Package 31722-0728-01. 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 Jun 18, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium chewable tablets are 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 ). 1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-728

What is NDC 31722-728?: 31722-728 is the product NDC for montelukast sodium, Montelukast 5 mg/1 tablet, chewable, listed with the FDA by Camber Pharmaceuticals, Inc.. 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 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 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
Montelukast Sodium	Montelukast 5 mg/1	Tablet, ChewableOral	DIRECT RX	72189-223