Montelukast NDC 68071-4034

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4034Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4034Add 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
68071-4034-9	68071403409	90 TABLET in 1 BOTTLE (68071-4034-9)Marketed from Aug 8, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary): montelukast
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203366
Marketing start: Feb 28, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68071-4034_1d7a445a-3c64-0235-e063-6394a90add16SPL ID 1d7a445a-3c64-0235-e063-6394a90add16SPL set ID 56429f04-97b6-06a9-e054-00144ff88e88RxCUI 200224UNII U1O3J18SFLUPC 0368071403497
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

N468071403409 followed by a unit qualifier and the quantity

Package 68071-4034-09. 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 17, 2024.

Indications (excerpt from the label)

Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older ( 1.3 ). 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)