NDC 68071-1652

MONTELUKAST

Montelukast

MONTELUKAST is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Montelukast Sodium.

• Product ID: 68071-1652_66d5e6a0-7bec-5344-e053-2a91aa0aa48c
• NDC: 68071-1652
• Product Type: Human Prescription Drug
• Proprietary Name: MONTELUKAST
• Generic Name: Montelukast
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202859
• Labeler Name: NuCare Pharmaceuticals,Inc.
• Substance Name: MONTELUKAST SODIUM
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68071-1652-9

90 TABLET, FILM COATED in 1 BOTTLE (68071-1652-9)

• Marketing Start Date: 2018-03-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68071-1652-9 [68071165209]

MONTELUKAST TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202859
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-07
• Marketing End Date: 2019-12-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-15

Drug Details

Active Ingredients

Ingredient	Strength
MONTELUKAST SODIUM	10 mg/1

OpenFDA Data

• SPL SET ID: 66d5e6a0-7beb-5344-e053-2a91aa0aa48c
• Manufacturer:
  • NuCare Pharmaceuticals,Inc.
• UNII:
  • U1O3J18SFL
• RxNorm Concept Unique ID - RxCUI:
  • 200224

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