What is NDC 13668-081?

13668-081 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 13668-081 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0081Add 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
13668-081-05	1366800810513668008105	500 TABLET in 1 BOTTLE (13668-081-05)Marketed from Aug 3, 2012
13668-081-30	1366800813013668008130	30 TABLET in 1 BOTTLE (13668-081-30)Marketed from Aug 3, 2012
13668-081-32	1366800813213668008132	3200 TABLET in 1 BOTTLE (13668-081-32)Marketed from Aug 3, 2012
13668-081-74	1366800817413668008174	100 TABLET in 1 CARTON (13668-081-74)Marketed from Aug 3, 2012
13668-081-90	1366800819013668008190	90 TABLET in 1 BOTTLE (13668-081-90)Marketed from Aug 3, 2012

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 Sodium
Generic name (nonproprietary): montelukast sodium
Active ingredients: Montelukast sodium — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201515
Marketing start: Aug 3, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 13668-081_3ad1ce49-1a92-4068-9006-04fe04136a62SPL ID 3ad1ce49-1a92-4068-9006-04fe04136a62SPL set ID da038cf6-cfad-43a4-ab8e-d81d028d6087RxCUI 200224, 242438, 311759, 351246UNII U1O3J18SFLUPC 0313668079302
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

N413668008105 followed by a unit qualifier and the quantity

Package 13668-0081-05. 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 12 months 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 6 months 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 the pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-081

What is NDC 13668-081?: 13668-081 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 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?: Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8617	68788-8617-0368788-8617-0668788-8617-09
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

All 71 Montelukast Sodium NDCs

Other NDCs under ANDA 201515

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

FDA NDC Directory listings under ANDA 201515
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Proficient Rx LP	63187-430
Montelukast Sodium	Montelukast sodium 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8610