Prescription drug · ANDA

Montelukast Sodium NDC 42291-622

Montelukast sodium 4 mg/1 · Tablet, Chewable · Oral · AvKARE

NDC codes

FDA NDC Directory
Product NDC (as listed)42291-622Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0622Add 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 NDC11-digit (billing)PackageCopy
42291-622-10422910622101000 TABLET, CHEWABLE in 1 BOTTLE (42291-622-10)Marketed from Aug 4, 2016
42291-622-304229106223030 TABLET, CHEWABLE in 1 BOTTLE (42291-622-30)Marketed from Jan 4, 2013
42291-622-904229106229090 TABLET, CHEWABLE in 1 BOTTLE (42291-622-90)Marketed from Jan 4, 2013

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
AvKARE
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200405
Marketing start
Listing expires
Other FDA classes
Leukotriene Receptor Antagonists (Mechanism)
Identifiers
Product ID 42291-622_4617d4b7-780e-f9ce-e063-6294a90aa00bSPL ID 4617d4b7-780e-f9ce-e063-6294a90aa00bSPL set ID ed2caffa-a75c-1c27-ae30-2d8280eaea7dRxCUI 200224, 242438, 311759UNII U1O3J18SFLUPC 0342291623101, 0342291623309
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

N442291062210 followed by a unit qualifier and the quantity

Package 42291-0622-10. 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 .

Indications (excerpt from the label)

Montelukast sodium tablets 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 (1.3) . 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200405

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

FDA NDC Directory listings under ANDA 200405
ProductStrengthForm · routeLabelerProduct NDC
Montelukast SodiumMontelukast sodium 4 mg/1Tablet, ChewableOralChartwell RX, LLC62135-781
Montelukast SodiumMontelukast sodium 5 mg/1Tablet, ChewableOralChartwell RX, LLC62135-782
Montelukast SodiumMontelukast sodium 4 mg/1Tablet, ChewableOralAvPAK50268-573
Montelukast SodiumMontelukast sodium 5 mg/1Tablet, ChewableOralAvPAK50268-574
Montelukast SodiumMontelukast sodium 4 mg/1Tablet, ChewableOralProficient Rx LP71205-189
Montelukast SodiumMontelukast sodium 5 mg/1Tablet, ChewableOralAvKARE42291-623
Montelukast SodiumMontelukast sodium 5 mg/1Tablet, ChewableOralProficient Rx LP63187-896
Montelukast SodiumMontelukast sodium 4 mg/1Tablet, ChewableOralLannett Company, Inc.62175-204
Montelukast SodiumMontelukast sodium 5 mg/1Tablet, ChewableOralLannett Company, Inc.62175-205

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Montelukast Sodium NDC 42291-622 | Med-Code