NDC 42291-748

Sildenafil

Sildenafil

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

Product ID42291-748_7d791848-dd19-a47b-e053-2a91aa0ab43a
NDC42291-748
Product TypeHuman Prescription Drug
Proprietary NameSildenafil
Generic NameSildenafil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-29
Marketing CategoryANDA / ANDA
Application NumberANDA077342
Labeler NameAvKARE, Inc.
Substance NameSILDENAFIL CITRATE
Active Ingredient Strength100 mg/1
Pharm ClassesPhosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-748-01

100 TABLET, FILM COATED in 1 BOTTLE (42291-748-01)
Marketing Start Date2018-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-748-30 [42291074830]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-06 [42291074806]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-02 [42291074802]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-12 [42291074812]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-01 [42291074801]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-04 [42291074804]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-29

NDC 42291-748-18 [42291074818]

Sildenafil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077342
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-18

Drug Details

Active Ingredients

IngredientStrength
SILDENAFIL CITRATE100 mg/1

OpenFDA Data

SPL SET ID:6d5b01df-db24-06bd-e053-2991aa0ac22f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314228
  • 312950
  • 314229
    • UPC Code
  • 0342291748309
  • 0342291747302
  • 0342291746305

    • 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"

    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.