NDC 64380-786

roflumilast

Roflumilast

roflumilast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Roflumilast.

Product ID64380-786_80893058-39db-41a5-bd81-874ed92bc8c9
NDC64380-786
Product TypeHuman Prescription Drug
Proprietary Nameroflumilast
Generic NameRoflumilast
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-10-13
Marketing CategoryANDA /
Application NumberANDA208247
Labeler NameStrides Pharma Science Limited
Substance NameROFLUMILAST
Active Ingredient Strength500 ug/1
Pharm ClassesPhosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64380-786-01

30 TABLET in 1 BOTTLE (64380-786-01)
Marketing Start Date2022-10-13
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "roflumilast" or generic name "Roflumilast"

NDCBrand NameGeneric Name
0378-1905RoflumilastRoflumilast
13668-476RoflumilastRoflumilast
31722-623RoflumilastRoflumilast
42571-259ROFLUMILASTRoflumilast
43547-005ROFLUMILASTroflumilast
64380-786roflumilastROFLUMILAST
68382-969RoflumilastRoflumilast
70771-1674RoflumilastRoflumilast
72205-200RoflumilastRoflumilast
72205-201RoflumilastRoflumilast
80610-130roflumilastroflumilast
0310-0088Daliresproflumilast
0310-0095Daliresproflumilast
55154-4625Daliresproflumilast

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