NDC 70954-168

Sildenafil

Sildenafil Citrate

Sildenafil is a Oral For Suspension in the Human Prescription Drug category. It is labeled and distributed by Novitium Pharma Llc. The primary component is Sildenafil Citrate.

Product ID70954-168_083da718-e934-4941-b083-a19b4ebe3935
NDC70954-168
Product TypeHuman Prescription Drug
Proprietary NameSildenafil
Generic NameSildenafil Citrate
Dosage FormFor Suspension
Route of AdministrationORAL
Marketing Start Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA212260
Labeler NameNovitium Pharma LLC
Substance NameSILDENAFIL CITRATE
Active Ingredient Strength10 mg/mL
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70954-168-10

1 BOTTLE in 1 CARTON (70954-168-10) > 112 mL in 1 BOTTLE
Marketing Start Date2019-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70954-168-10 [70954016810]

Sildenafil FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA212260
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
SILDENAFIL CITRATE10 mg/mL

Pharmacological Class

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

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

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.