What is NDC 63187-626?

63187-626 is the product NDC for Montelukast, Montelukast sodium 5 mg/1 tablet, chewable, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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 63187-626 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-626Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0626Add 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
63187-626-30	6318706263063187062630	30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30)Marketed from Dec 1, 2018
63187-626-60	6318706266063187062660	60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60)Marketed from Dec 1, 2018
63187-626-90	6318706269063187062690	90 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90)Marketed from Dec 1, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203037
Marketing start: Dec 1, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 63187-626_b54fe609-9c8c-4ca3-bd5c-8f3ab197f969SPL ID b54fe609-9c8c-4ca3-bd5c-8f3ab197f969SPL set ID 9705627c-283e-4743-b261-cfeb88d96e9bRxCUI 242438UNII 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

N463187062630 followed by a unit qualifier and the quantity

Package 63187-0626-30. 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 Nov 1, 2019.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Montelukast sodium tablets are 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 ( 1.3 ). 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-626

What is NDC 63187-626?: 63187-626 is the product NDC for Montelukast, Montelukast sodium 5 mg/1 tablet, chewable, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 63187. 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 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