Montelukast Sodium NDC 13668-080

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-080Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0080Add 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
13668-080-05	13668008005	500 TABLET, CHEWABLE in 1 BOTTLE (13668-080-05)Marketed from Aug 3, 2012
13668-080-30	13668008030	30 TABLET, CHEWABLE in 1 BOTTLE (13668-080-30)Marketed from Aug 3, 2012
13668-080-90	13668008090	90 TABLET, CHEWABLE in 1 BOTTLE (13668-080-90)Marketed from Aug 3, 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 — 5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090984
Marketing start: Aug 3, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 13668-080_3ad1ce49-1a92-4068-9006-04fe04136a62SPL ID 3ad1ce49-1a92-4068-9006-04fe04136a62SPL set ID da038cf6-cfad-43a4-ab8e-d81d028d6087RxCUI 200224, 242438, 311759, 351246UNII U1O3J18SFLUPC 0313668079302
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

N413668008005 followed by a unit qualifier and the quantity

Package 13668-0080-05. 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 Jul 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Montelukast sodium 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. 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 for the pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090984

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

FDA NDC Directory listings under ANDA 090984
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Proficient Rx LP	63187-550
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Torrent Pharmaceuticals Limited	13668-079
Montelukast Sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	PD-Rx Pharmaceuticals, Inc.	43063-381