NDC 72865-175

Montelukast

Montelukast

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

Product ID72865-175_bb0f591e-db58-2061-e053-2a95a90aaf29
NDC72865-175
Product TypeHuman Prescription Drug
Proprietary NameMontelukast
Generic NameMontelukast
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA202843
Labeler NameXLCare Pharmaceuticals Inc.
Substance NameMONTELUKAST SODIUM
Active Ingredient Strength10 mg/1
Pharm ClassesLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 72865-175-10

1000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10)
Marketing Start Date2021-02-11
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0143-9649MONTELUKASTMONTELUKAST
0143-9650MONTELUKASTMONTELUKAST
0143-9651MONTELUKASTMONTELUKAST
0781-5554MontelukastMontelukast
0781-5555MontelukastMontelukast
0781-5560MontelukastMontelukast
0904-6808MontelukastMontelukast
31722-726MontelukastMontelukast
33342-102MontelukastMontelukast
51128-501MONTELUKASTMONTELUKAST
51128-502MONTELUKASTMONTELUKAST
51128-503MONTELUKASTMONTELUKAST
54458-890MontelukastMontelukast
55154-8075MontelukastMontelukast
63187-626MONTELUKASTMONTELUKAST
63629-4886MontelukastMontelukast
68001-361MontelukastMontelukast
68071-1652MONTELUKASTMONTELUKAST
68071-4034MontelukastMontelukast
68645-560MontelukastMontelukast
68788-7387MONTELUKASTMONTELUKAST
69452-105MONTELUKASTMONTELUKAST
69452-107MONTELUKASTMONTELUKAST
69452-106MONTELUKASTMONTELUKAST
70518-1031MontelukastMontelukast
70518-2603MontelukastMontelukast
27241-017MONTELUKAST SODIUMMONTELUKAST
53217-357MONTELUKAST SODIUMMONTELUKAST
63629-8235MONTELUKAST SODIUMMONTELUKAST
65162-732Montelukast SodiumMontelukast
65162-771Montelukast SodiumMontelukast
65162-772Montelukast SodiumMontelukast

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