NDC codes

FDA NDC Directory
Product NDC (as listed)0781-5560Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-5560Add 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
0781-5560-130078155601310 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)Marketed from Jun 13, 2025
0781-5560-310078155603130 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)Marketed from Jun 13, 2025
0781-5560-920078155609290 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92)Marketed from Jun 13, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route
Oral
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200889
Marketing start
Listing expires
Other FDA classes
Leukotriene Receptor Antagonists (Mechanism)
Identifiers
Product ID 0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7SPL ID e593fadb-cac5-44ca-8fd6-93c626cd40a7SPL set ID 6d69e73a-76cb-4ece-9cf9-e9adb4f523b4RxCUI 200224UNII U1O3J18SFLUPC 0307815560317
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

N400781556013 followed by a unit qualifier and the quantity

Package 00781-5560-13. 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

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