NDC 33342-102

Montelukast

Montelukast

Montelukast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Montelukast Sodium.

• Product ID: 33342-102_20eecb71-3239-49b6-ae2c-126acc978124
• NDC: 33342-102
• Product Type: Human Prescription Drug
• Proprietary Name: Montelukast
• Generic Name: Montelukast
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203366
• Labeler Name: Macleods Pharmaceuticals Limited
• 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: 2022-12-31

Packaging

NDC 33342-102-07

30 TABLET in 1 BOTTLE (33342-102-07)

• Marketing Start Date: 2014-09-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 33342-102-12 [33342010212]

Montelukast TABLET

• Marketing Category: ANDA
• Application Number: ANDA203366
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-11

NDC 33342-102-15 [33342010215]

Montelukast TABLET

• Marketing Category: ANDA
• Application Number: ANDA203366
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-11

NDC 33342-102-07 [33342010207]

Montelukast TABLET

• Marketing Category: ANDA
• Application Number: ANDA203366
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-11

NDC 33342-102-10 [33342010210]

Montelukast TABLET

• Marketing Category: ANDA
• Application Number: ANDA203366
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-11

NDC 33342-102-39 [33342010239]

Montelukast TABLET

• Marketing Category: ANDA
• Application Number: ANDA203366
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-11

Drug Details

Active Ingredients

Ingredient	Strength
MONTELUKAST SODIUM	10 mg/1

OpenFDA Data

• SPL SET ID: e0c5b856-3f70-4ca6-9763-a90673bb82fb
• Manufacturer:
  • Macleods Pharmaceuticals Limited
• UNII:
  • U1O3J18SFL
• RxNorm Concept Unique ID - RxCUI:
  • 200224

Pharmacological Class

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

Medicade Reported Pricing

33342010215 MONTELUKAST SOD 10 MG TABLET

Pricing Unit: EA | Drug Type:

33342010210 MONTELUKAST SOD 10 MG TABLET

Pricing Unit: EA | Drug Type:

33342010207 MONTELUKAST SOD 10 MG TABLET

Pricing Unit: EA | Drug Type:

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