What is NDC 68788-8099?

68788-8099 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 68788-8099 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8099Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8099Add 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
68788-8099-3	6878880990368788809903	30 TABLET, FILM COATED in 1 BOTTLE (68788-8099-3)Marketed from Oct 6, 2021
68788-8099-6	6878880990668788809906	60 TABLET, FILM COATED in 1 BOTTLE (68788-8099-6)Marketed from Oct 6, 2021
68788-8099-9	6878880990968788809909	90 TABLET, FILM COATED in 1 BOTTLE (68788-8099-9)Marketed from Oct 6, 2021

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
Generic name (nonproprietary): montelukast
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals, Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202843
Marketing start: Oct 6, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-8099_9fe0882e-a654-4c1c-8d46-9f5fc7daadb3SPL ID 9fe0882e-a654-4c1c-8d46-9f5fc7daadb3SPL set ID 94642db1-5c75-44c4-92b4-8385b486df82RxCUI 200224UNII U1O3J18SFL
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

N468788809903 followed by a unit qualifier and the quantity

Package 68788-8099-03. 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 Jul 28, 2026. 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 • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older • 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 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8099

What is NDC 68788-8099?: 68788-8099 is the product NDC for Montelukast, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, 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?: Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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	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
Montelukast	Montelukast sodium 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3855	68071-3855-03

All 16 Montelukast NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1979
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-009
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-175
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-8075
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3133
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-556
Montelukastmontelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6109
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6108
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-418
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-726
Montelukast	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-563
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6808