What is NDC 0781-5560?

0781-5560 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Montelukast?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Montelukast NDC 0781-5560 | National Drug Code

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 NDC	11-digit (billing)	Package
0781-5560-13	0078155601300781556013	10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06)Marketed from Jun 13, 2025
0781-5560-31	0078155603100781556031	30 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31)Marketed from Jun 13, 2025
0781-5560-92	0078155609200781556092	90 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 IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200889
Marketing start: Aug 3, 2012
Listing expires: Dec 31, 2026
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

Current FDA label (SPL), effective Jun 13, 2025. 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5560

What is NDC 0781-5560?: 0781-5560 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Montelukast.
What is the active ingredient?: Montelukast sodium.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Montelukast?: 15 other product NDCs are listed under this name. See all Montelukast NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Montelukast NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Coupler LLC	67046-2060	67046-2060-03
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-009	82009-0009-10
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-556	50268-0556-15
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-8099	68788-8099-0368788-8099-0668788-8099-09
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3133	70518-3133-0070518-3133-0170518-3133-02
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-563	71610-0563-30
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-175	72865-0175-1072865-0175-3072865-0175-90
Montelukast	Montelukast sodium 10 mg/1	TabletOral	BluePoint Laboratories	68001-361	68001-0361-0368001-0361-0468001-0361-05
Montelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Proficient Rx LP	63187-626	63187-0626-3063187-0626-6063187-0626-90
Montelukast	Montelukast sodium 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-102	33342-0102-0733342-0102-1033342-0102-12+2 more

All 16 Montelukast NDCs