What is NDC 68788-8617?

68788-8617 is the product NDC for montelukast sodium, 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 sodium?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

montelukast sodium NDC 68788-8617 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8617Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8617Add 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
68788-8617-3	6878886170368788861703	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3)Marketed from Mar 28, 2024
68788-8617-6	6878886170668788861706	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6)Marketed from Mar 28, 2024
68788-8617-9	6878886170968788861709	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9)Marketed from Mar 28, 2024

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
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204290
Marketing start: Mar 28, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-8617_92c7019c-7aba-4a08-ab99-2acb438d7a44SPL ID 92c7019c-7aba-4a08-ab99-2acb438d7a44SPL set ID 1eeb3123-9e93-4681-8096-800a7c7acf8aRxCUI 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

N468788861703 followed by a unit qualifier and the quantity

Package 68788-8617-03. 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 is a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 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 is indicated for t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8617

What is NDC 68788-8617?: 68788-8617 is the product NDC for montelukast sodium, 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 sodium.
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 sodium?: 70 other product NDCs are listed under this name. See all montelukast sodium 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 sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4753	70518-4753-00
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8610	68788-8610-0368788-8610-0668788-8610-09
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-100	16571-0100-0916571-0100-10
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-418	72189-0418-3072189-0418-90
Montelukast Sodium	Montelukast 5 mg/1	Tablet, ChewableOral	DIRECT RX	72189-223	72189-0223-30
Montelukast Sodiummontelukast	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Amneal Pharmaceuticals LLC	65162-771	65162-0771-03
Montelukast Sodiummontelukast	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Amneal Pharmaceuticals LLC	65162-772	65162-0772-03
montelukast sodium	Montelukast 5 mg/1	Tablet, ChewableOral	Preferred Pharmaceuticals, Inc.	68788-7669	68788-7669-0168788-7669-0268788-7669-03+3 more
Montelukast Sodium	Montelukast sodium 4 mg/1	GranuleOral	Aurobindo Pharma Limited	59651-329	59651-0329-30
montelukast sodium	Montelukast sodium 4 mg/1	Tablet, ChewableOral	Unichem Pharmaceuticals (USA), Inc.	29300-221	29300-0221-1029300-0221-1329300-0221-19

All 71 montelukast sodium NDCs

Other NDCs under ANDA 204290

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

FDA NDC Directory listings under ANDA 204290
Product	Strength	Form · route	Labeler	Product NDC
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-220
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5278
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-181
montelukast sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1995