NDC 51128-503

MONTELUKAST

Montelukast

MONTELUKAST is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Recipharm Pharmaservices Private Limited. The primary component is Montelukast Sodium.

• Product ID: 51128-503_9eeede6e-480e-4b27-e053-2a95a90a34dc
• NDC: 51128-503
• Product Type: Human Prescription Drug
• Proprietary Name: MONTELUKAST
• Generic Name: Montelukast
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203037
• Labeler Name: Recipharm Pharmaservices Private Limited
• 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: 2021-12-31

Packaging

NDC 51128-503-01

30 TABLET, CHEWABLE in 1 BOTTLE (51128-503-01)

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51128-503-03 [51128050303]

MONTELUKAST TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA203037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-19

NDC 51128-503-01 [51128050301]

MONTELUKAST TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA203037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-19

NDC 51128-503-02 [51128050302]

MONTELUKAST TABLET, CHEWABLE

• Marketing Category: ANDA
• Application Number: ANDA203037
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-19

Drug Details

Active Ingredients

Ingredient	Strength
MONTELUKAST SODIUM	5 mg/1

OpenFDA Data

• SPL SET ID: 8216e292-2a06-4de0-bcb6-d282eb61d302
• Manufacturer:
  • Recipharm Pharmaservices Private Limited
• UNII:
  • U1O3J18SFL
• RxNorm Concept Unique ID - RxCUI:
  • 200224
  • 311759
  • 242438
• UPC Code:
  • 0351128503011
  • 0351128502014
  • 0351128501017

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0143-9649	MONTELUKAST	MONTELUKAST
0143-9650	MONTELUKAST	MONTELUKAST
0143-9651	MONTELUKAST	MONTELUKAST
0781-5554	Montelukast	Montelukast
0781-5555	Montelukast	Montelukast
0781-5560	Montelukast	Montelukast
0904-6808	Montelukast	Montelukast
31722-726	Montelukast	Montelukast
33342-102	Montelukast	Montelukast
50090-6108	Montelukast	Montelukast
50268-556	Montelukast	Montelukast
51128-501	MONTELUKAST	MONTELUKAST
51128-502	MONTELUKAST	MONTELUKAST
51128-503	MONTELUKAST	MONTELUKAST
54458-890	Montelukast	Montelukast
55154-8075	Montelukast	Montelukast
63187-626	MONTELUKAST	MONTELUKAST
63629-4886	Montelukast	Montelukast
68001-361	Montelukast	Montelukast
68071-1652	MONTELUKAST	MONTELUKAST
68071-4034	Montelukast	Montelukast
68645-560	Montelukast	Montelukast
68788-7387	MONTELUKAST	MONTELUKAST
69452-105	MONTELUKAST	MONTELUKAST
69452-107	MONTELUKAST	MONTELUKAST
69452-106	MONTELUKAST	MONTELUKAST
70518-1031	Montelukast	Montelukast
70518-2603	Montelukast	Montelukast
27241-017	MONTELUKAST SODIUM	MONTELUKAST
53217-357	MONTELUKAST SODIUM	MONTELUKAST