NDC 0378-1657

Sildenafil

Sildinafil

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 ID0378-1657_17c6b6b9-ad60-40f8-b7f0-1ce76954ab57
NDC0378-1657
Product TypeHuman Prescription Drug
Proprietary NameSildenafil
Generic NameSildinafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA201150
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSILDENAFIL CITRATE
Active Ingredient Strength20 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1657-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1657-77)
Marketing Start Date2012-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1657-05 [00378165705]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-09
Marketing End Date2016-05-27

NDC 0378-1657-77 [00378165777]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201150
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-09

Drug Details

Active Ingredients

IngredientStrength
SILDENAFIL CITRATE20 mg/1

OpenFDA Data

SPL SET ID:f7eec0c1-7054-44da-aa46-f3c33a939471
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 577033
    • UPC Code
  • 0303781657778

    • 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 "Sildinafil"

    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
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