Prescription drug · ANDA

Montelukast Sodium NDC 55154-8075

Montelukast sodium 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-8075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-8075Add 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
55154-8075-05515480750010 BLISTER PACK in 1 BAG (55154-8075-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2014

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 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 55154-8075_6aaff257-5e8a-4ffb-ad72-92f0c0c67614SPL ID 6aaff257-5e8a-4ffb-ad72-92f0c0c67614
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

N455154807500 followed by a unit qualifier and the quantity

Package 55154-8075-00. 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

The FDA listing for this product does not reference a label (SPL) set.

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 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
Montelukast SodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-726

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Montelukast Sodium NDC 55154-8075 | Med-Code