Montelukast NDC 68001-361

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-361Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0361Add 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
68001-361-03	68001036103	500 TABLET in 1 BOTTLE (68001-361-03)Marketed from Jun 29, 2018
68001-361-04	68001036104	30 TABLET in 1 BOTTLE (68001-361-04)Marketed from Jun 29, 2018
68001-361-05	68001036105	90 TABLET in 1 BOTTLE (68001-361-05)Marketed from Jun 29, 2018

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
Generic name (nonproprietary): montelukast
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203366
Marketing start: Jun 29, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68001-361_d9dbbe03-bcc4-1af7-e053-2a95a90a8053SPL ID d9dbbe03-bcc4-1af7-e053-2a95a90a8053SPL set ID 4c411d3e-47b6-481b-b846-419ed4cbb947RxCUI 200224UNII U1O3J18SFLUPC 0368001361040, 0368001361033, 0368001361057
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

N468001036103 followed by a unit qualifier and the quantity

Package 68001-0361-03. 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 Mar 10, 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 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. 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 tablets are i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203366

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

FDA NDC Directory listings under ANDA 203366
Product	Strength	Form · route	Labeler	Product NDC
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Coupler LLC	67046-2060
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3855
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-102
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4034