Montelukast Sodium NDC 68071-4047

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4047Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4047Add 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	Copy
68071-4047-3	68071404703	30 TABLET, FILM COATED in 1 BOTTLE (68071-4047-3)Marketed from Aug 10, 2017

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: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202717
Marketing start: Apr 11, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 68071-4047_1d7a4391-15ea-178a-e063-6294a90a80c1SPL ID 1d7a4391-15ea-178a-e063-6294a90a80c1SPL set ID 566a8fd7-fc00-2297-e054-00144ff8d46cRxCUI 200224UNII U1O3J18SFLUPC 0368071404739
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

N468071404703 followed by a unit qualifier and the quantity

Package 68071-4047-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 202717

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

FDA NDC Directory listings under ANDA 202717
Product	Strength	Form · route	Labeler	Product NDC
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3355
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0514
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-781
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-119
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-762
Montelukast Sodium	Montelukast sodium 10 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1926