NDC 53217-357

MONTELUKAST SODIUM

Montelukast

MONTELUKAST SODIUM is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Montelukast Sodium.

• Product ID: 53217-357_a58c1900-948f-4535-9811-78e075005a16
• NDC: 53217-357
• Product Type: Human Prescription Drug
• Proprietary Name: MONTELUKAST SODIUM
• Generic Name: Montelukast
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203328
• Labeler Name: Aidarex Pharmaceuticals LLC
• Substance Name: MONTELUKAST SODIUM
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53217-357-30

30 TABLET, CHEWABLE in 1 BOTTLE (53217-357-30)

• Marketing Start Date: 2017-12-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53217-357-30 [53217035730]

MONTELUKAST SODIUM TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA203328
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-26
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MONTELUKAST SODIUM	5 mg/1

OpenFDA Data

• SPL SET ID: 147725da-4c8b-4608-87a9-053311d0aba0
• Manufacturer:
  • Aidarex Pharmaceuticals LLC
• UNII:
  • U1O3J18SFL
• RxNorm Concept Unique ID - RxCUI:
  • 242438

Pharmacological Class

• Leukotriene Receptor Antagonist [EPC]
• Leukotriene Receptor Antagonists [MoA]

NDC Crossover Matching brand name "MONTELUKAST SODIUM" or generic name "Montelukast"

NDC	Brand Name	Generic Name
0054-0259	Montelukast Sodium	Montelukast Sodium
0054-0288	Montelukast Sodium	Montelukast Sodium
0054-0289	Montelukast Sodium	Montelukast Sodium
0093-7424	Montelukast Sodium	Montelukast Sodium
0093-7425	Montelukast Sodium	Montelukast Sodium
68001-248	montelukast sodium	montelukast sodium
68071-4047	Montelukast Sodium	Montelukast Sodium
68071-4054	Montelukast Sodium	Montelukast Sodium
68071-3355	Montelukast Sodium	Montelukast Sodium
68084-875	Montelukast Sodium	Montelukast Sodium
68151-3494	Montelukast Sodium	Montelukast Sodium
68151-4186	Montelukast Sodium	Montelukast Sodium
68151-3498	Montelukast Sodium	Montelukast Sodium
68151-4338	Montelukast Sodium	Montelukast Sodium
68462-392	montelukast sodium	montelukast sodium
68788-6410	Montelukast Sodium	Montelukast Sodium
68788-6946	Montelukast Sodium	Montelukast Sodium
68788-8988	Montelukast Sodium	Montelukast Sodium
68788-7064	Montelukast Sodium	Montelukast Sodium
68788-9438	Montelukast Sodium	Montelukast Sodium
68788-9439	Montelukast Sodium	Montelukast Sodium
70436-091	Montelukast Sodium	Montelukast Sodium
70436-090	Montelukast Sodium	Montelukast Sodium
70518-0172	Montelukast Sodium	Montelukast Sodium
70518-0294	MONTELUKAST SODIUM	MONTELUKAST SODIUM
70518-0684	Montelukast Sodium	Montelukast Sodium
70518-0331	Montelukast Sodium	Montelukast Sodium
70518-0805	Montelukast Sodium	Montelukast Sodium
70518-1075	Montelukast Sodium	Montelukast Sodium
70518-1085	Montelukast Sodium	Montelukast Sodium
70518-1784	Montelukast Sodium	Montelukast Sodium
0603-4655	Montelukast Sodium	Montelukast Sodium
70934-202	Montelukast Sodium	Montelukast Sodium
71205-128	MONTELUKAST SODIUM	MONTELUKAST SODIUM
0603-4653	Montelukast Sodium	Montelukast Sodium
0603-4654	Montelukast Sodium	Montelukast Sodium
71335-0629	MONTELUKAST SODIUM	MONTELUKAST SODIUM
71335-0611	Montelukast Sodium	Montelukast Sodium
71205-181	montelukast sodium	montelukast sodium
71335-0514	Montelukast Sodium	Montelukast Sodium
71335-0620	Montelukast Sodium	Montelukast Sodium
71335-0301	Montelukast Sodium	Montelukast Sodium
71610-129	Montelukast Sodium	Montelukast Sodium
71610-026	Montelukast Sodium	Montelukast Sodium
71610-051	Montelukast Sodium	Montelukast Sodium
0615-7748	Montelukast Sodium	Montelukast Sodium
0615-7983	Montelukast Sodium	Montelukast Sodium
0904-6529	Montelukast Sodium	Montelukast Sodium
13668-079	Montelukast Sodium	Montelukast Sodium
13668-081	Montelukast Sodium	Montelukast Sodium