NDC codes

FDA NDC Directory
Product NDC (as listed)31722-726Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0726Add 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
31722-726-0131722072601100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01)Marketed from Sep 10, 2014
31722-726-10317220726101000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10)Marketed from Sep 10, 2014
31722-726-303172207263030 TABLET, FILM COATED in 1 BOTTLE (31722-726-30)Marketed from Sep 10, 2014
31722-726-323172207263210 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31)Marketed from Sep 10, 2014
31722-726-903172207269090 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)Marketed from Sep 10, 2014

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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202843
Marketing start
Listing expires
Other FDA classes
Leukotriene Receptor Antagonists (Mechanism)
Identifiers
Product ID 31722-726_30387eb8-222d-146e-e063-6294a90a12a7SPL ID 30387eb8-222d-146e-e063-6294a90a12a7SPL set ID 97a682c2-7e00-4d07-a5ac-4436c977f842RxCUI 200224UNII U1O3J18SFLUPC 0331722726306
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

N431722072601 followed by a unit qualifier and the quantity

Package 31722-0726-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 202843

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

FDA NDC Directory listings under ANDA 202843
ProductStrengthForm · routeLabelerProduct NDC
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralAvPAK50268-556
Montelukast SodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8075
Montelukast SodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralDirect_Rx72189-418
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-8099
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-563
Montelukastmontelukast sodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6109
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6108
Montelukast SodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6808
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-175
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3133
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1979
MontelukastMontelukast sodium 10 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-009

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