NDC 0378-1659

Sildenafil

Sildenafil

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

Product ID0378-1659_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
NDC0378-1659
Product TypeHuman Prescription Drug
Proprietary NameSildenafil
Generic NameSildenafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA201171
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSILDENAFIL CITRATE
Active Ingredient Strength50 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1659-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1659-93)
Marketing Start Date2019-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1659-93 [00378165993]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201171
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-04

Drug Details

Pharmacological Class

  • Phosphodiesterase 5 Inhibitor [EPC]
  • Phosphodiesterase 5 Inhibitors [MoA]

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

NDCBrand NameGeneric Name
0093-5341SildenafilSildenafil
0093-5342SildenafilSildenafil
0093-5343SildenafilSildenafil
0093-5517SildenafilSildenafil
0179-0160Sildenafilsildenafil citrate
0378-1657Sildenafilsildinafil
0378-1658Sildenafilsildenafil
0378-1659Sildenafilsildenafil
0378-1660Sildenafilsildenafil
0591-4050SildenafilSildenafil
68001-176SildenafilSildenafil
68001-363SildenafilSildenafil
68071-2072SildenafilSildenafil
68071-1979SildenafilSildenafil
68071-1687SildenafilSildenafil
68071-3137SildenafilSildenafil
68071-3329SildenafilSildenafil
68071-4517SildenafilSildenafil
68071-4599SildenafilSildenafil
68071-4617SildenafilSildenafil
68071-4674SildenafilSildenafil
68084-869SildenafilSildenafil
68788-7379SildenafilSildenafil
68788-7218SildenafilSildenafil
70518-0438SildenafilSildenafil
70518-1216SildenafilSildenafil
70518-1844SildenafilSildenafil
70859-015SildenafilSildenafil
71205-088SildenafilSildenafil
71205-220SildenafilSildenafil
71335-0969SildenafilSildenafil
71335-1005SildenafilSildenafil
71335-0288SildenafilSildenafil
71335-1028SildenafilSildenafil
71610-237SildenafilSildenafil
76519-1135SildenafilSildenafil
76519-1216SILDENAFILSILDENAFIL
76519-1218SILDENAFILSILDENAFIL
27241-124SildenafilSildenafil
31722-710SildenafilSildenafil
31722-776SildenafilSildenafil
31722-711SildenafilSildenafil
31722-709SildenafilSildenafil
33342-121SildenafilSildenafil
42291-747SildenafilSildenafil
42291-748SildenafilSildenafil
42291-746SildenafilSildenafil
42291-749SildenafilSildenafil
43063-668SildenafilSildenafil
43063-550SildenafilSildenafil
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.