Montelukast Sodium NDC 55111-593

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-593Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0593Add 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
55111-593-05	55111059305	500 TABLET, CHEWABLE in 1 BOTTLE (55111-593-05)Marketed from Aug 6, 2012
55111-593-30	55111059330	30 TABLET, CHEWABLE in 1 BOTTLE (55111-593-30)Marketed from Aug 6, 2012
55111-593-78	55111059378	10 BLISTER PACK in 1 CARTON (55111-593-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-593-79)Marketed from Aug 6, 2012
55111-593-90	55111059390	90 TABLET, CHEWABLE in 1 BOTTLE (55111-593-90)Marketed from Aug 6, 2012

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: Dr.Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201581
Marketing start: Aug 6, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 55111-593_8bc013e8-5324-099d-e603-d78012b126bdSPL ID 8bc013e8-5324-099d-e603-d78012b126bdSPL set ID 3d4451a9-d73d-b9de-68ec-853bfeff6e4bRxCUI 200224, 242438, 311759UNII 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

N455111059305 followed by a unit qualifier and the quantity

Package 55111-0593-05. 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 Oct 30, 2022. 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 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 ). Limitations of Use: • Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium is indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201581

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

FDA NDC Directory listings under ANDA 201581
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Dr.Reddy's Laboratories Limited	55111-594