Montelukast Sodium NDC 13668-531

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0531Add 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
13668-531-94	13668053194	30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11)Marketed from Mar 30, 2017

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/500mg
Dosage form: Granule
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210431
Marketing start: Mar 30, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 13668-531_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

N413668053194 followed by a unit qualifier and the quantity

Package 13668-0531-94. 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.

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