NDC 0378-5204

Montelukast Sodium

Montelukast Sodium

Montelukast Sodium is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc. The primary component is Montelukast Sod.

Product ID0378-5204_57fcd11a-014e-421b-965c-187b64f28676
NDC0378-5204
Product TypeHuman Prescription Drug
Proprietary NameMontelukast Sodium
Generic NameMontelukast Sodium
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-08-03
Marketing End Date2019-03-31
Marketing CategoryANDA /
Application NumberANDA079142
Labeler NameMylan Pharmaceuticals Inc
Substance NameMONTELUKAST SOD
Active Ingredient Strength4 mg/1
Pharm ClassesLeukotriene Rec
NDC Exclude FlagN

Packaging

NDC SPL Data Element Entries

NDC 0378-5204-77 [00378520477]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA079142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03
Marketing End Date2015-02-20

NDC 0378-5204-05 [00378520405]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA079142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-03
Marketing End Date2015-02-20

NDC 0378-5204-93 [00378520493]

Montelukast Sodium TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA079142
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-03
Marketing End Date2019-03-31

Drug Details

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

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

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