montelukast sodium NDC 29300-221

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0221Add 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
29300-221-10	29300022110	1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-10)Marketed from Aug 20, 2018
29300-221-13	29300022113	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-13)Marketed from Aug 20, 2018
29300-221-19	29300022119	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-19)Marketed from Aug 20, 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 sodium
Generic name (nonproprietary): montelukast sodium
Active ingredients: Montelukast sodium — 4 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208621
Marketing start: Aug 20, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 29300-221_57f07f65-1a14-4423-9da8-975664ca0684SPL ID 57f07f65-1a14-4423-9da8-975664ca0684SPL set ID 9e375c07-70db-458c-9336-22a7037b0a5fRxCUI 200224, 242438, 311759UNII U1O3J18SFLUPC 0329300221138, 0329300222135
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

N429300022110 followed by a unit qualifier and the quantity

Package 29300-0221-10. 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 12, 2023. 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 the proph…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208621

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

FDA NDC Directory listings under ANDA 208621
Product	Strength	Form · route	Labeler	Product NDC
montelukast sodium	Montelukast sodium 5 mg/1	Tablet, ChewableOral	Unichem Pharmaceuticals (USA), Inc.	29300-222